BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET TIP

    MDR report key: 2161186 · Received July 13, 2011

    Report

    Report Number
    2124215-2011-07136
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVN
    PMA / PMN Number
    K893957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING EXPLANT OF THIS DEVICE FOR NORMAL BATTERY DEPLETION, THE SETSCREWS WERE STUCK. SEVERAL TROUBLESHOOTING TECHNIQUES WERE USED, AND ULTIMATELY A BONE CUTTER WAS NEEDED. WHILE THE PHYSICIAN WAS CUTTING THE DEVICE HEADER, IT COMPLETELY DETACHED FROM THE DEVICE AND THE PATIENT WENT ASYSTOLIC FOR SEVERAL SECONDS. THE PHYSICIAN HOOKED UP THE CURRENT LEADS TO PACE EXTERNALLY THROUGH THE PACING SYSTEM ANALYZER (PSA) WHILE THE SURGERY WAS COMPLETED. THE RIGHT ATRIAL (RA) LEAD SUSTAINED INSULATION DAMAGE DURING THE DEVICE EXPLANT PROCEDURE SO THIS LEAD WAS SURGICALLY ABANDONED. IN AN EFFORT TO MINIMIZE LEADS IN THIS PATIENT, THE PHYSICIAN PLACED THE CHRONIC RIGHT VENTRICULAR (RV) LEAD IN THE RA PORT OF THE DEVICE. PRIOR TO MOVING THE CHRONIC RV LEAD INTO THE ATRIAL PORT, IT HAD BEEN EXHIBITING HIGHER THAN DESIRED THRESHOLDS. A NEW RV LEAD WAS THEN PLACED INTO THE VENTRICLE. TO DATE, THERE HAVE BEEN NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET TIP IMPLANTABLE LEAD NVN HISTORICAL PUERTO RICO 4269

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Life Threatening| R 4269| 1286| S603| 1230| 4136