BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3905757 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11108
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    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

    (B)(4). 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 LOSS OF CAPTURE DURING A ROUTINE FOLLOW-UP. A CHEST X-RAY WAS PERFORMED AND LEAD DISLODGEMENT WAS OBSERVED ALONG WITH EVIDENCE OF TWIDDLERS SYNDROME. THE PATIENT WAS ADMITTED INTO THE HOSPITAL AND LATER UNDERWENT A REVISION PROCEDURE. THIS PRODUCT WAS REMOVED FROM SERVICE AND A NEW LEAD WAS SUCCESSFULLY PLACED. THIS PRODUCT IS NOT EXPECTED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382427 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R F140| 0293