BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 1925478 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13887
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH THE RIGHT VENTRICULAR AND RIGHT ATRIAL LEADS HAD LOW IMPEDANCE, "POCKET" NOISE, APPARENT LEAD FRACTURES, AND THEIR UNIPOLAR IMPEDANCE WAS HIGHER THAN THEIR BIPOLAR IMPEDANCE, INDICATING POSSIBLE INSULATION FAILURE. IT WAS FURTHER REPORTED THAT LEADS MAY HAVE BEEN DAMAGED BY RECOIL FROM A RIFLE SHOULDERED ON THE SAME SIDE AS THE DEVICE. BOTH LEADS WERE CAPPED 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
    1 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4024 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R (B)(4) STENT GRAFT| (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) STENT GRAFT