BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2791057 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14797
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 18, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. EVALUATION SUMMARY: THE DEVICE AND LEADS WERE RETURNED AND ANALYZED. (B)(4) THE DEVICE HAD NORMAL BATTERY DEPLETION AND MET EXPECTED LONGEVITY. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED. NO ANOMALIES WERE FOUND. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED. ALL CONDUCTORS WERE STRETCHED ALONG WITH THE LEAD. THE INNER INSULATION WAS TORN. APPARENT EXPLANT DAMAGE WAS NOTED. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING APPARENT PECTORAL MUSCLE / POCKET STIMULATION. THE PATIENT WAS "DEEPLY SEDATED AND ON TERMINAL HOSPICE CARE" AT THE TIME OF THE STIMULATION. THE PATIENT HAS SINCE EXPIRED IN A MANNER UNRELATED TO THIS EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other