BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3050101 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03162
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    October 29, 2012
    Report Date
    February 14, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT WAS BROUGHT INTO THE CLINIC FOR EVALUATION. THERE WAS ONE NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODE STORED WHICH REVEALED NOISE. THE PATIENT REPORTED TO HAVE HAD A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) UNIT ON THEIR NECK. IT WAS STATED THAT THE TENS UNIT WAS PLACED IMMEDIATELY AFTER A NECK LAMINECTOMY AND THE STORED NOISE EPISODE IS DIRECTLY ASSOCIATED WITH THE TIME OF THE NECK LAMINECTOMY. THE PATIENT HAD THE TENS UNIT ON IN THE CLINIC AND THE SHOCK LEAD IMPEDANCE WAS TESTED AND GOT 23 OHMS. WHEN THE TENS UNIT WAS TURNED OFF THE IMPEDANCE WAS 53-58 OHMS. ADDITIONAL INFORMATION HAS BEEN PROVIDED THAT THIS IS A DEVICE SPECIFIC ISSUE, NOT A LEAD ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150183 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR 0157| 1860| E102