BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2153679 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-11064
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS CURRENTLY INDICATE THAT THESE LEADS REMAIN IMPLANTED. 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 REPORTED THAT THE LEADS HAD DISLODGED. IT IS UNKNOWN WHICH SPECIFIC LEADS HAD DISLODGED. THE PATIENT REPORTED THERE WAS A REVISION PROCEDURE PERFORMED IN WHICH THE LEADS "KEPT POPPING OUT". IT IS UNKNOWN IF THE LEADS WERE EXPLANTED OR REPOSITIONED. ATTEMPTS TO OBTAIN THIS INFORMATION HAVE BEEN MADE BUT WERE UNSUCCESSFUL. ADDITIONAL INFORMATION WAS ALSO REPORTED THAT THE PATIENT HAD A BLOOD CLOT IN THE ARM. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THE LEAD DISLODGEMENT ALLEGATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 0184| H170| 4470| 4543