BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3921702 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-11799
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 21, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. 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 HIGH OUT RANGE PACE LEAD IMPEDANCE MEASUREMENTS WHICH WAS DETECTED VIA THE PATIENT'S REMOTE MONITORING SYSTEM. ADDITIONALLY, THE LEAD EXHIBITED LOSS OF CAPTURE WITH ASYSTOLE GREATER THAN 2 SECONDS AND DAMAGE TO THE LEAD BODY AND INSULATION WAS ALSO NOTED. A SURGICAL INTERVENTION WAS SUBSEQUENTLY PERFORMED. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. ADDITIONAL INFORMATION INDICATED THAT A LEAD FRACTURE WAS CONCLUSIVELY DETERMINED THROUGH X-RAY AND FLUOROSCOPY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399869 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R T125| E110| 1297| 0184| 5076