BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3213615 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09353
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    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 THE PATIENT WITH THIS IMPLANTED RIGHT VENTRICULAR (RV) LEAD EXPERIENCED MUSCLE STIMULATION, WAS HOSPITALIZED WHERE IT WAS FOUND VIA A CHEST X-RAY THAT THIS LEAD WAS DISLODGED. THE LEAD ALSO EXHIBITED LOSS OF CAPTURE. THIS PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD WAS REPOSITIONED. DURING THE PROCEDURE, IT WAS NOTED VIA FLUOROSCOPY THAT THE HELIX WAS COMPLETELY RETRACTED. THIS PATIENT WAS REPORTED TO HAVE TWIDDLER'S SYNDROME SO THEY SUSPECTED THE MECHANISM OF THE TWIDDLING TO CAUSE THE HELIX TO RETRACT AND DISLODGE THE LEAD. THIS LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS IN SERVICE WITH GOOD DIAGNOSTIC MEASUREMENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314348 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 0292| E160