BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOVERY

    MDR report key: 3211045 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08337
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. VISUAL INSPECTION CONFIRMED THE ALLEGATION OF THE APPEARANCE OF A SUBSTANCE PEELING OFF THE CASE OF THE DEVICE. REVIEW OF DEVICE RECORDS NOTED THE DEVICE HAD BEEN IMPLANTED FOR 126 MONTHS. THE SUBSTANCE WAS CONFIRMED TO BE THE SILICONE COATING ON THE DEVICE CASE. THE AMOUNT OF WEAR SEEN WITH THIS DEVICE IS APPROPRIATE AND EXPECTED FOR THE LENGTH OF TIME IT WAS IMPLANTED. ADDITIONALLY, THE VENTRICULAR TIP SETSCREW WAS NOTED TO BE IN THE FULLY RETRACTED POSITION WITH THE TIP OF A WRENCH BROKEN OFF IN THE HEX SLOT. THE SETSCREW RETAINER WASHER WAS DISTENDED (BENT OUTWARD) AS A RESULT OF EXCESSIVE TURNING OF THE SETSCREW IN THE ATTEMPT TO LOOSEN IT. ANALYSIS CONFIRMED THE SETSCREW WAS STUCK IN THE UP POSITION. THE DEVICE WAS NOTED TO PACE AND SENSE NORMALLY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS BEING REPLACED DUE TO NORMAL BATTERY DEPLETION. AT THE CHANGE-OUT PROCEDURE, THE RIGHT VENTRICULAR (RV) SET SCREW WAS STUCK. ATTEMPTS TO LOOSEN THE SET SCREW WERE UNSUCCESSFUL. THE PHYSICIAN CUT AND SURGICALLY ABANDONED THE RV LEAD AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. WHEN THE GENERATOR WAS REMOVED FROM THE POCKET THERE APPEARED TO BE A SUBSTANCE PEELING OFF THE DEVICE CAN (LIKELY THE SILICONE COVERING THAT WAS OVER THE CASE OF THE PACEMAKER). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310019 DISCOVERY IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1175

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR K062| MISMATCH| 4136| 1175| 291-03