BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2954500 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02388
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 14, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 5524M IMPLANTABLE PACING LEAD 1995 (B)(6). (B)(4). LEAD NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD FRACTURED. A FRACTURE IN THE LEAD WAS OBSERVED ON X-RAY AND WAS VISIBLE UPON REMOVAL. LEAD NOISE WAS ALSO NOTED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59331 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5024M-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR