BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3921729 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-12390
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    PHYSICIAN

    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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW, OUT OF RANGE, PACING LEAD IMPEDANCE MEASUREMENT OF LESS THAN 200 OHMS. OVERSENSING WAS NOTED BUT WITHOUT PACING INHIBITION. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT X-RAY AND FLUOROSCOPIC EVALUATION DID NOT PROVIDE ANY CONCLUSIVE INFORMATION AS TO WHAT THE REASON FOR THE LOW IMPEDANCE MEASUREMENT WAS. THE LEAD WAS ASSESSED DURING REVISION AND SUBCLAVIAN CRUSH WAS NOTED THAT VISUALLY AFFECTED THE LEAD INSULATION. NOISE AND OVERSENSING WAS ALSO OBSERVED DURING PATIENT ARM MOVEMENT. SUBSEQUENTLY, THIS LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED WHILE THE DEVICE REMAINS IN SERVICE. MOREOVER, THE PATIENT HAD A PENDING APPOINTMENT WITH THE PHYSICIAN FOR FOLLOW-UP. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400296 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R 0184| 4470| E110