BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211101 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08871
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS PARTIALLY ABANDONED AND 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 RIGHT VENTRICULAR (RV) LEAD WAS PARTIALLY CAPPED AT THE RATE/SENSE PORTION OF THE LEAD BECAUSE OF A LOSS OF CAPTURE (LOC) AT MAXIMUM OUTPUTS AND NO SENSING. THE SHOCKING PORTION OF THE LEAD REMAINS IN SERVICE. THE PHYSICIAN BELIEVES IT MAY BE A RESULT FROM CHANGES IN THE PATIENT'S TISSUE CONDITION. A NEW NON BOSTON SCIENTIFIC LEAD WAS IMPLANTED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311247 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Life Threatening| R 5076| 4549| N119| MISMATCH| 4555| 4135| 0184