BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2161590 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-06866
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 21, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONGOING ALERTS CONTINUE FOR THIS ISSUE WHICH OCCUR DURING THE USE OF THE BONE HEALER STIMULATOR. THE PATIENT WILL CONTINUE TO USE THIS DEVICE FOR A FEW MONTHS.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THESE PRODUCTS REMAIN IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED A SHOCK IMPEDANCE OF LESS THAN 20 OHMS. THE PATIENT WAS FURTHER EVALUATED IN WHICH THE PATIENT REPORTED FALLING RECENTLY. A FEW MONTHS PRIOR THEY HAD BROKEN THEIR SHOULDER. THE PATIENT RECENTLY STARTED USING A BONE STIMULATOR IN WHICH THE ELECTRICAL PADS ARE APPROXIMATELY NINE INCHES FROM THE DEVICE. THE DATE THE PATIENT HAD RECENTLY USED THIS STIMULATOR CORRESPONDS TO THE DATE OF THE LOW SHOCK IMPEDANCE MEASUREMENTS. THE REPRESENTATIVE REPORTED THAT WHILE TAKING MANUAL SHOCK IMPEDANCE MEASUREMENTS WHEN THE STIMULATOR WAS TURNED ON LESS THAN 20 OHMS AND NOISE WAS PRESENT. HOWEVER, THERE WAS NO OVERSENSING PRESENT DURING TESTING AND THERE WERE NO EPISODES IN THE LOGBOOK. EVERYTHING WAS NORMAL WHEN THE BONE STIMULATOR WAS TURNED OFF. TECHNICAL SERVICES DISCUSSED TROUBLESHOOTING AND THE POTENTIAL OF OVERSENSING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR 0184| E110| 4469