BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3213070 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10412
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, NO RETURN OF PRODUCT IS INTENDED. WITHOUT A RETURN OF PRODUCT, THE REPORTED ALLEGATION CANNOT BE CONFIRMED NOR DENIED. 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 DURING A FOLLOW-UP VISIT, THIS RIGHT VENTRICULAR LEAD DISPLAYED OVERSENSING WHICH RESULTED IN INAPPROPRIATE THERAPY. NOISE AND OVERSENSING WERE REVEALED ON BOTH THE PACE/SENSE AND SHOCK CHANNELS, HOWEVER THERE WAS NO ASYSTOLE AS A RESULT OF THIS ISSUE. SHOCK IMPEDANCE WAS STABLE. FLUOROSCOPY REVEALED A SUSPECTED LEAD FRACTURE AT THE LEVEL OF THE PROXIMAL COIL, HOWEVER NO X-RAY WAS PERFORMED. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED AND REVIEWED THE DATA. IT WAS THOUGHT THERE WAS EITHER A FRACTURE OR INSULATION DAMAGE BETWEEN THE LEAD'S YOKE AND THE DEVICE. A REVISION PROCEDURE WAS PERFORMED. DIFFICULTY WAS ENCOUNTERED REMOVING THIS LEAD; THE LEAD WAS SURGICALLY ABANDONED (HOWEVER NOT CAPPED) AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311941 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R