BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 3052695 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04167
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 6, 2013
    Report Date
    April 15, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT THE DEVICE WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. VISUAL INSPECTION CONFIRMED THE HEADER WAS SEPARATED FROM THE DEVICE CASE. THE MEDICAL ADHESIVE (MA), USED TO AFFIX THE HEADER TO THE DEVICE CASE, DID NOT REMAIN ON THE BOTTOM OF THE HEADER WITH NO MA ON THE CASE AS IT DID NOT ADHERE. LOOSE/SEPARATED HEADERS ARE DUE TO AN INSUFFICIENT BOND STRENGTH BETWEEN THE HEADER AND THE DEVICE CASE. THE DEVICE WAS ARCHIVED AT BOSTON SCIENTIFIC.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE REPLACEMENT PROCEDURE, THE PHYSICIAN OBSERVED CORROSION ON THE CONDUCTORS IN THE HEADER OF THE DEVICE. IN ADDITION, THE HEADER WAS FOUND TO HAVE PULLED AWAY FROM THE DEVICE AND OVERSENSING WAS OBSERVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155507 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L