BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3050091 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03552
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    August 15, 2012
    Report Date
    February 20, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER ACTION WAS TAKEN ON THIS DEVICE AT THE TIME OF THE EVENT. IT WAS NOTED THAT 4 MONTHS AFTER THIS EVENT, THE DEVICE WAS EXPLANTED DUE TO AN UNRELATED PATIENT CONDITION OF INFECTION. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL DEVICE REPLACEMENT, THIS SUB Q ARRAY WAS NOTED TO HAVE AN INSULATION BREACH RESULTING IN LOW SHOCK IMPEDANCES LESS THAN 20 OHMS WITH THE NEW PULSE GENERATOR THE TRIAD CONFIGURATION. IT WAS SUSPECTED THAT THE INSULATION FAILURE OCCURRED DUE TO THE ARRAY RUBBING AGAINST THE PREVIOUS DEVICE WHILE IMPLANTED. THIS NEW PULSE GENERATOR WAS IMPLANTED, AND FURTHER LOW SHOCK IMPEDANCES WERE NOTED. A REPROGRAMMING OF THE DEVICE TO A COIL TO CAN CONFIGURATION REMEDIED THE ISSUE. NO FURTHER ACTION WAS TAKEN AS IT WAS NOTED THE PATIENT CONDITION HAD IMPROVED SINCE THE LAST CHANGEOUT AND TACHYCARDIA SHOCK THERAPY WAS NOT CONSIDERED ESSENTIAL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152183 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N164

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 1388TC| H219| 0085| 0157| H155| 4518| N164