BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2913131 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-16345
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    November 29, 2012
    Report Date
    December 9, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 LEAD PRESENTED TO THE EMERGENCY ROOM AFTER EXPERIENCING MUSCLE STIMULATION. UPON DEVICE INTERROGATION, THE LEAD WAS NOTED TO BE UNDERSENSING. IT WAS ALSO REPORTED THAT THE PATIENT WAS A TWIDDLER AND THE LEAD WAS NOTED TO HAVE BEEN PULLED BACK INTO THE SUPERIOR VENA CAVA. THE PATIENT UNDERWENT A LEAD REVISION WHERE THE LEAD WAS SUCCESSFULLY REPOSITIONED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19640 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 4470| 0181| E110