BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3792840 · Received May 6, 2014

    Report

    Report Number
    2649622-2014-04816
    Event Type
    Death
    Date Received
    May 6, 2014
    Date of Event
    March 19, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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. ATTEMPT(S) FOR ADDITIONAL INFORMATION FROM THE PHYSICIAN AND FUNERAL HOME WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. PRODUCT ID 5076-52 IMPLANTED: 2006 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY # PRODUCT ID# 5076-45 A PROXIMAL PORTION WAS RECEIVED MEASURING 17 CM. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND, VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE.

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED FROM (B)(4) CREMATORY WITH LIMITED INFORMATION. INFORMATION IDENTIFIED IN THE PAPERWORK INDICATED THE PATIENT DIED APPROXIMATELY TWO MONTHS POST IMPLANT OF THE IPG SYSTEM. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272523 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Death ADDRL1 IPG