BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 3153395 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05997
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCE ON THE VENTRICULAR LEAD HAD A SIGNIFICANT INCREASE AND IS NOW HIGH. THE THRESHOLD ON THE LEAD HAS ALSO INCREASED. THE DEVICE WAS REPROGRAMMED AND LEAD REVISION HAS BEEN DISCUSSED. THE LEAD CURRENTLY REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256394 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5024M

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention ADDR01 IMPLANTABLE PULSE GENERATOR