PATCH

Description of Event or Problem

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD HAD VARYING SHOCK IMPEDANCE READINGS WITH SOME GREATER THAN 125 OHMS. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED TROUBLESHOOTING A DELIVERY A COMMANDED MINIMUM AND MAXIMUM SHOCK TO TEST THE INTEGRITY OF THE LEAD. TO DATE, THERE HAVE BEEN NO REPORTED PATIENT SYMPTOMS ASSOCIATED WITH THIS CLINICAL OBSERVATION. ADDITIONAL INFORMATION PROVIDED STATED THAT THE DEVICE WAS EMITTING TONES DUE TO THE OUT OF RANGE IMPEDANCES MEASUREMENTS. TS AGAIN RECOMMENDED INDUCTION TESTING AND ALSO DISCUSSED THAT THERE COULD BE A HIT ON THE LONGEVITY OF THIS DEVICE IF IT CONTINUES TO EMIT TONES. ADDITIONAL INFORMATION INDICATES THAT THIS SYSTEM CONTINUES TO EXHIBIT OUT OF RANGE SHOCKING IMPEDANCES. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AGAIN RECOMMENDED INDUCTION TESTING. THE PATIENT WAS TO UNDERGO A REVISION PROCEDURE IN THE NEAR FUTURE. ADDITIONAL INFORMATION INDICATES THAT THIS PATIENT UNDERWENT A REVISION PROCEDURE AND THIS LEAD REMAINS IMPLANTED WITH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE PHYSICIAN HAD PERFORMED DEFIBRILLATION THRESHOLD (DFT) TESTING WITH A 31 JOULE SHOCK AND IMPEDANCES WERE GOOD. THE PHYSICIAN HAS ELECTED TO LEAVE THE LEAD AS IS.

Additional Manufacturer Narrative

AS OF TODAY, THE AVAILABLE INFORMATION SUGGESTS THIS ICD AND RV LEAD REMAIN IN SERVICE WITHOUT ADDITIONAL COMPLICATION. IF ANY ADDITIONAL INFORMATION RELATED TO THIS INCIDENT BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.