BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3051367 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03446
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 19, 2013
    Report Date
    July 23, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH DEVICES AND RV LEAD REMAIN IN SERVICE . AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD REVEALED A RISE IN SHOCK IMPEDANCES GREATER THAN 200 OHMS (THE RV LEAD MODEL AND SERIAL NUMBER ARE UNKNOWN AT THIS TIME AND THE DEVICE IS IMPLANTED IN THE PATIENT'S ABDOMEN). A REVISION PROCEDURE WAS PERFORMED. DURING THE REVISION PROCEDURE THE LEAD WAS CONNECTED TO THE NEW DEVICE AND CONTINUED TO REVEAL HIGH SHOCK IMPEDANCE GREATER THAN 200 OHMS; EXCEPT FOR THE PROXIMAL COIL. ALL OTHER MEASUREMENTS WERE CONFIRMED NORMAL AND WITHIN RANGE WITH THE NEW DEVICE. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AGENT WAS CONTACTED FOR REVIEW OF THE HIGH SHOCK IMPEDANCES. THE AGENT ADVISED THAT EXCLUDING THE EPICARDIAL PATCH, THE SHOCK MEASUREMENTS WERE IN RANGE. A CONNECTION ISSUE WAS SUSPECTED DUE TO THE OUT OF RANGE MEASUREMENTS PREVIOUSLY REPORTED. IT WAS NOTED THAT THE SHOCK IMPEDANCE MEASURING SYSTEM WITH THE PATCH WAS MEASURING CURRENT AND THIS MAY HAVE INFLUENCED A GOOD OUTCOME OF THE MEASUREMENTS DUE TO A WIDER MEASURING SURFACE. THE AGENT ADVISED THAT THE PHYSICIAN PERFORM SHOCK TESTING AND AN X-RAY FOR REVIEW. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND LEAD REMAIN IN SERVICE AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THE RIGHT VENTRICULAR (RV) LEAD IS A BOSTON SCIENTIFIC PRODUCT. THE SHOCK IMPEDANCE REMAINS HIGH AND OUT OF RANGE. ADDITIONALLY, NOISE HAS BEEN OBSERVED ON THE RV CHANNEL. THE NOISE HAS BEEN OVERSENSED BUT IS NOT IMPACTING PACING THERAPY DUE TO THE PATIENT'S INTRINSIC RHYTHM. THE PHYSICIAN HAS ELECTED TO CONTINUE MONITORING THE PATIENT VIA THE REMOTE MONITORING SYSTEM. THIS ICD AND THE RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149663 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F161

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening