BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR MAX

    MDR report key: 2894534 · Received November 10, 2008

    Report

    Report Number
    2124215-2008-10439
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    July 1, 2008
    Report Date
    November 7, 2008
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-875/897-03
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ALL SETSCREWS MOVED FREELY AND OPERATED NORMALLY. MICROSCOPIC VISUAL INSPECTION NOTED THAT THE VENTRICLE RETAINER RINGS WERE BENT UPWARD. THIS WOULD INDICATE THAT EXCESSIVE FORCE WAS USED TO RETRACT THE SETSCREWS. NO OTHER IRREGULARITIES WERE OBSERVED. THE DEVICE HEADER WAS SEPARATED FROM THE HEADER AND A CUT WAS MADE BEHIND THE PROXIMAL CONNECTOR BLOCKS TO FURTHER INSPECT THE INNER SEAL RINGS. MICROSCOPIC VISUAL INSPECTION OF THE INNER SEAL RINGS REVEALED EVIDENCE OF SILICONE TO SILICONE BONDING IN THE VENTRICLE INNER SEAL RINGS. NO EVIDENCE OF SILICONE TO SILICONE BONDING IN THE ATRIAL INNER SEAL RINGS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT DURING A ROUTINE DEVICE CHANGE OUT PROCEDURE, THE VENTRICULAR LEAD COULD NOT BE REMOVED FROM THIS DEVICE HEADER. IT WAS NOTED THAT THE SETSCREWS WERE FULLY LOOSENED. HEPARINIZED SALINE WAS USED AND EVENTUALLY, THE LEAD WAS SUCCESSFULLY REMOVED. NO ADVERSE PT EFFECTS WERE OBSERVED. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR MAX IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1270

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 4243