REACTIV8

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT FELL DOWN THE STAIRS AND BUMPED THE IMPLANTABLE PULSE GENERATOR (IPG). THE TIME AND DATE OF THE FALL WERE UNKNOWN, BUT THE PATIENT WAS IMPLANTED WITH THE REACTIVES SYSTEM ON (B)(6) 2024. FOLLOWING THE FALL, THE NURSE REPORTED SOME DRAINAGE (OOZING) FROM THE WOUND. THE PATIENT UNDERWENT A SURGICAL PROCEDURE IN WHICH THE SURGEON WASHED OUT THE IPG AND POCKET SITE, PENDING THE SWAB TEST RESULT. THERE WERE NO REPORTS OF COMPLICATIONS ASSOCIATED WITH THE PROCEDURE. MAINSTAY WAS INFORMED TWO DAYS AFTER THE PROCEDURE. THE DEVICE HISTORY RECORD WAS REVIEWED; NO NONCONFORMANCES RELEVANT TO THE EVENT WERE FOUND.

Additional Manufacturer Narrative

MML REFERENCE (B)(4).

Additional Manufacturer Narrative

MML REFERENCE #: (B)(4). B2_OTHER: WOUND WASHOUT. THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS DURING THE WASH-OUT PROCEDURE. THE CULTURE RESULTS WERE NEGATIVE EXCEPT FOR POSITIVE FOR WHITE BLOOD CELLS. FOLLOWING THE PROCEDURE, THE REACTIV8 SYSTEM WAS ACTIVATED VIA PROGRAMMING THE REACTIV8 IPG TO ALLOW THE PATIENT TO INITIATE BILATERAL STIMULATION (WHEN INITIATED BY THE PATIENT). THE DEVICE REMAINS IMPLANTED AND FUNCTIONAL. UPDATED B5.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT FELL DOWN THE STAIRS AND BUMPED THE IMPLANTABLE PULSE GENERATOR (IPG). THE TIME AND DATE OF THE FALL WERE UNKNOWN, BUT THE PATIENT WAS IMPLANTED WITH THE REACTIV8 SYSTEM ON (B)(6) 2024. FOLLOWING THE FALL, THE NURSE REPORTED SOME DRAINAGE (OOZING) FROM THE WOUND. THE PATIENT UNDERWENT A SURGICAL PROCEDURE IN WHICH THE SURGEON WASHED OUT THE IPG AND POCKET SITE, PENDING THE SWAB TEST RESULT. THERE WERE NO REPORTS OF COMPLICATIONS ASSOCIATED WITH THE PROCEDURE. MAINSTAY WAS INFORMED TWO DAYS AFTER THE PROCEDURE. THERE WAS NO MAINSTAY MEDICAL REPRESENTATIVE PRESENT AT THE TIME OF THE EVENT. THE DEVICE HISTORY RECORD WAS REVIEWED; NO NONCONFORMANCES RELEVANT TO THE EVENT WERE FOUND.