BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2013-06838

    MDR report key: 3210226 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06838
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INFORMATION KNOWN AT THIS TIME. WHEN ADDITIONAL INFORMAITON BECOMES AVAILABLE, THIS EVENT WILL BE UPDAETD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS ATRIAL LEAD WAS HOSPITALIZED. THIS ATRIAL LEAD DISPLAYED OVERSENSING. AN X-RAY REVEALED THE LEAD WAS DISLODGED. AS THERE WAS CONCERN REGARDING INAPPROPRIATE THERAPY DELIVERY, A DECIISION WAS MADE TO REPROGRAM THE DEVICE TO A SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RATHER THAN OFF. THE PATIENT WAS NOTED TO HAVE "TWIDDLERS SYNDROME". NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310045 NVN GUIDANT PUERTO RICO BV BRADY LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 030-247| 0465| 4285| 1283| 1010| 0950