INNOVO, TYPE NUMBER 207

Description of Event or Problem

ON THE (B)(6) 2023 THE CUSTOMER REPORTED THAT THEY EXPERIENCED AN INCREASED IN HEART RATE DURING THE TIME PERIOD THEY WERE USING THE INNOVO DEVICE, APPROXIMATELY WITHIN 6 WEEKS OF USING THE DEVICE DURING THE MONTHS IN (B)(6) 2021. THE CUSTOMER REPORTED HAVING INTERMITTENT HIGH HEART RATE NOT LINKED TO USE OF THE INNOVO DEVICE AT THAT TIME. THE CUSTOMER ALSO REPORTED EXPERIENCING ERROR MESSAGES ON THE INNOVO CONTROLLER DURING THE USE OF THE INNOVO SHORTS. THE ATLANTIC THERAPEUTICS CUSTOMER CARE TEAM PROVIDED TROUBLESHOOTING STEPS. THE CUSTOMER DID NOT ADVISE THE CUSTOMER CARE TEAM OF THE INCREASED HEART RATE DURING THESE CALLS WHICH TOOK PLACE IN 2021. THE CUSTOMER COLLAPSED AT THEIR HOME ON (B)(6) 2021 AND WAS ADMITTED TO HOSPITAL ON THE (B)(6) 2021 TO UNDERGO EMERGENCY CARDIOVERSION TO BRING HER HEART RATE DOWN. CUSTOMER WAS DISCHARGED AFTER HAVING HEART SHOCKED BACK INTO SINUS RHYTHM. ON(B)(6) 2021 THE CUSTOMER WAS RE-ADMITTED TO HOSPITAL "HEART RATE BECAME DANGEROUSLY (LIFE THREATENINGLY) HIGH AND UNDERWENT FURTHER TREATMENT, 24 HOUR ECG FOR 5 DAYS, VARIOUS SCANS AND TESTS, NO DETAIL PROVIDED. A CARDIOLOGIST RECOMMENDED UNDERGOING CARDIAC ABLATION. THE CUSTOMER UNDERWENT THIS SURGERY IN (B)(6) 2022 AND DEVELOPED PTSD POST SURGERY. AF (ARTERIAL FIBRILLATION) WAS CONTROLLED AT THIS TIME HOWEVER CUSTOMER REPORTED REPEAT EPISODES IN (B)(6) 2023. CUSTOMER WAS ADVISED BY HER PHYSICIAN TO CEASE USING ELECTRICAL STIMULATION.

Additional Manufacturer Narrative

ATLANTIC THERAPEUTICS HAVE REQUESTED THE DEVICE TO BE RETURNED ON NUMEROUS OCCASIONS, WITHOUT SUCCESS AND AS OF (B)(6) 2023 CAN CONFIRM THAT THERE IS NO RESPONSE FROM THE CUSTOMER, THOUGH A PRE-PAID ENVELOPE HAS BEEN PROVIDED TO RETURN THE DEVICE. THEREFORE, TO DATE, EVALUATION OF THE DEVICE HAS NOT BEEN POSSIBLE. GIVEN THE INNOVO® DEVICES REFERRED TO IN THE COMPLAINT WERE PURCHASED FROM AN UNAUTHORISED DISTRIBUTOR (EBAY IN BOTH CASES), AT CANNOT VERIFY THE CONDITIONS UNDER WHICH THE DEVICE WAS SUBJECT TO, PRIOR TO USE. ADEQUATE TRACEABILITY INFORMATION HAS NOT BEEN PROVIDED TO DATE FROM THE CUSTOMER/USER, APART FROM THE PART NUMBER. FULL TRACEABILITY INFORMATION CANNOT BE ASCERTAINED.

Description of Event or Problem

INSUFFICIENT INFORMATION. NO DEFECT FOUND. ON THE (B)(6) 2023 THE CUSTOMER REPORTED THAT THEY EXPERIENCED AN INCREASED IN HEART RATE DURING THE TIME PERIOD THEY WERE USING THE INNOVO DEVICE. THE CUSTOMER DID NOT REPORT ANY ISSUES WITH HER HEART DURING THE USE OF THE INNOVO DEVICE IN 2021. THE ATLANTIC THERAPEUTICS CUSTOMER CARE TEAM PROVIDED TROUBLESHOOTING STEPS FOR A SIZE RELATED ISSUE ONLY IN 2021. IN (B)(6) 2023 THE CUSTOMER REPORTED A SERIOUS ADVERSE EVENT WHERE THE CUSTOMER SURMISED A POSSIBLE RELATIONSHIP BETWEEN THE SERIOUS ADVERSE EVENTS OCCURING IN SEPTEMBER 2021 AND THE USE OF THE INNOVO DEVICE. THE CUSTOMER'S PHYSICIAN DID NOT SUPPORT THE CAUSAL RELATIONSHIP. THE EVALUATION PERFORMED BY ATLANTIC THERAPEUTICS WAS INCONCLUSIVE. THE DEVICE HAS NOT BEEN RETURNED BY THE CUSTOMER FOR FURTHER EVALUATION, DESPITE MULTIPLE ATTEMPTS BY ATLANTIC THERAPEUTICS TO SECURE THE PRODUCT. THE CUSTOMER REPORTED THAT THEY COLLAPSED AT THEIR HOME ON (B)(6) 2021 AND WAS ADMITTED TO HOSPITAL ON THE (B)(6) 2021 TO UNDERGO EMERGENCY CARDIOVERSION TO BRING HER HEART RATE DOWN. CUSTOMER WAS DISCHARGED AFTER HAVING HEART SHOCKED BACK INTO SINUS RHYTHM. ON THE (B)(6) 2021 THE CUSTOMER WAS RE-ADMITTED TO HOSPITAL "HEART RATE BECAME DANGEROUSLY (LIFE THREATENINGLY) HIGH AND UNDERWENT FURTHER TREATMENT, 24 HOUR ECG FOR 5 DAYS, VARIOUS SCANS AND TESTS, NO DETAIL PROVIDED. A CARDIOLOGIST RECOMMENDED UNDERGOING CARDIAC ABLATION. THE CUSTOMER UNDERWENT THIS SURGERY IN (B)(6) 2022 AND DEVELOPED PTSD POST SURGERY. AF (ARTERIAL FIBRILLATION) WAS CONTROLLED AT THIS TIME. CUSTOMER REPORTED REPEAT EPISODES OF INCREASED HEART RATE AGAIN IN FEBRUARY AND (B)(6) 2023. CUSTOMER WAS ADVISED BY HER PHYSICIAN TO CEASE USING ANY ELECTRICAL STIMULATION PRODUCTS THAT COULD EXACERBATE HER CONDITION. THIS SUPPORTS ATLANTIC THERAPEUTICS' INSTRUCTIONS FOR USE.

Additional Manufacturer Narrative

ATLANTIC THERAPEUTICS HAVE REQUESTED THE DEVICE TO BE RETURNED ON NUMEROUS OCCASIONS, WITHOUT SUCCESS AND AS OF 12 JUL 2023 CAN CONFIRM THAT THERE IS NO RESPONSE FROM THE CUSTOMER, THOUGH A PRE-PAID ENVELOPE HAS BEEN PROVIDED TO RETURN THE DEVICE. THEREFORE, TO DATE, EVALUATION OF THE DEVICE HAS NOT BEEN POSSIBLE. GIVEN THE INNOVO® DEVICES REFERRED TO IN THE COMPLAINT WERE PURCHASED FROM AN UNAUTHORISED DISTRIBUTOR (EBAY IN BOTH CASES), AT CANNOT VERIFY THE CONDITIONS UNDER WHICH THE DEVICE WAS SUBJECT TO, PRIOR TO USE. ADEQUATE TRACEABILITY INFORMATION HAS NOT BEEN PROVIDED TO DATE FROM THE CUSTOMER/USER, APART FROM THE PART NUMBER. FULL TRACEABILITY INFORMATION CANNOT BE ASCERTAINED. ADDITIONAL INFORMATION: THE INNOVO DEVICE WAS RETURNED ON THE 03RD OCTOBER 2023 AND INSPECTED FOR DEFECTS.THE INNOVO DEVICE WAS FOUND TO HAVE STRETCHED BEYOND ITS CAPACITY TO FUNCTION.

Description of Event or Problem

INSUFFICIENT INFORMATION. NO DEFECT FOUND. ON THE 09TH MARCH 2023 THE CUSTOMER REPORTED THAT THEY EXPERIENCED AN INCREASED IN HEART RATE DURING THE TIME PERIOD THEY WERE USING THE INNOVO DEVICE. THE CUSTOMER DID NOT REPORT ANY ISSUES WITH HER HEART DURING THE USE OF THE INNOVO DEVICE IN 2021. THE ATLANTIC THERAPEUTICS CUSTOMER CARE TEAM PROVIDED TROUBLESHOOTING STEPS FOR A SIZE RELATED ISSUE ONLY IN 2021. IN MARCH 2023 THE CUSTOMER REPORTED A SERIOUS ADVERSE EVENT WHERE THE CUSTOMER SURMISED A POSSIBLE RELATIONSHIP BETWEEN THE SERIOUS ADVERSE EVENTS OCCURING IN SEPTEMBER 2021 AND THE USE OF THE INNOVO DEVICE. THE CUSTOMER'S PHYSICIAN DID NOT SUPPORT THE CAUSAL RELATIONSHIP. THE EVALUATION PERFORMED BY ATLANTIC THERAPEUTICS WAS INCONCLUSIVE. THE DEVICE HAS NOT BEEN RETURNED BY THE CUSTOMER FOR FURTHER EVALUATION, DESPITE MULTIPLE ATTEMPTS BY ATLANTIC THERAPEUTICS TO SECURE THE PRODUCT. THE CUSTOMER REPORTED THAT THEY COLLAPSED AT THEIR HOME ON (B)(6) 2021 AND WAS ADMITTED TO HOSPITAL ON THE (B)(6) 2021 TO UNDERGO EMERGENCY CARDIOVERSION TO BRING HER HEART RATE DOWN. CUSTOMER WAS DISCHARGED AFTER HAVING HEART SHOCKED BACK INTO SINUS RHYTHM. ON THE (B)(6) 2021 THE CUSTOMER WAS RE-ADMITTED TO HOSPITAL "HEART RATE BECAME DANGEROUSLY (LIFE THREATENINGLY) HIGH AND UNDERWENT FURTHER TREATMENT, 24 HOUR ECG FOR 5 DAYS, VARIOUS SCANS AND TESTS, NO DETAIL PROVIDED. A CARDIOLOGIST RECOMMENDED UNDERGOING CARDIAC ABLATION. THE CUSTOMER UNDERWENT THIS SURGERY IN (B)(6) 2022 AND DEVELOPED PTSD POST SURGERY. AF (ARTERIAL FIBRILLATION) WAS CONTROLLED AT THIS TIME. CUSTOMER REPORTED REPEAT EPISODES OF INCREASED HEART RATE AGAIN IN (B)(6) 2023. CUSTOMER WAS ADVISED BY HER PHYSICIAN TO CEASE USING ANY ELECTRICAL STIMULATION PRODUCTS THAT COULD EXACERBATE HER CONDITION. THIS SUPPORTS ATLANTIC THERAPEUTICS' INSTRUCTIONS FOR USE. ADDITIONAL INFORMATION: THE INNOVO DEVICE WAS RETURNED ON THE 03RD OCTOBER 2023 AND INSPECTED FOR DEFECTS.THE INNOVO DEVICE WAS FOUND TO HAVE STRETCHED BEYOND ITS CAPACITY TO FUNCTION.