BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2952121 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00395
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    February 28, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE OUTER INSULATION HAD A DEPRESSION BREACH, THE PROXIMAL CONDUCTOR WAS PULLED/STRETCHED/OVERSTRESSED, THE DISTAL CONDUCTOR WAS PULLED/STRETCHED/OVERSTRESSED, THE PROXIMAL CONDUCTOR WAS MELTED, THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR, THERE WAS BLOOD ON THE DISTAL CONDUCTOR, THE OUTER INSULATION WAS MELTED, AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION; FULL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH IMPEDANCE AND HIGH THRESHOLD, WITH A LEAD WARNING AND POLARITY SWITCH. THE RV (RIGHT VENTRICULAR) LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56707 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5024M-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R