BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210989 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08870
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    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 DURING ROUTINE FOLLOW-UP POST IMPLANT, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED DECREASED R-WAVE AMPLITUDE AND HIGH PACING THRESHOLDS THAT IMPACTED THERAPY DELIVERY. HOWEVER, THE PATIENT HAD A GOOD UNDERLYING RHYTHM, SO NO ISSUES WERE REPORTED. IT WAS DETERMINED THE LEAD HAD DISLODGED. SURGICAL INTERVENTION WAS PERFORMED AND THE LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311155 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 4592| 0292| N160| 4469