BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3922052 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-12962
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 7, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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) DISPLAYED A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT AS OBSERVED VIA REMOTE PATIENT MONITORING SYSTEM. OVERSENSING OF NOISE WAS NOTED BUT DID NOT LEAD TO PACING INHIBITION. NOISE WAS REPRODUCIBLE WITH ISOMETRICS AND POCKET MANIPULATION. THE DEVICE WAS REPORTED TO HAVE MIGRATED NEAR THE ARMPIT. ADDITIONAL INFORMATION INDICATED THAT THE CAUSE WAS NOT DETERMINED. THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401085 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R 4135| 0180| E110