BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX

    MDR report key: 3141337 · Received June 3, 2013

    Report

    Report Number
    2649622-2013-05480
    Event Type
    Death
    Date Received
    June 3, 2013
    Date of Event
    December 24, 2012
    Report Date
    June 19, 2013
    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. THE DEVICES ASSOCIATED WITH THIS ADVERSE OUTCOME WERE RETURNED AND THE PATIENT WAS IDENTIFIED AS BEING DECEASED. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. HOWEVER, IF ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. (B)(4). A ADDR01 IMPLANTABLE PULSE GENERATOR (IPG), IMPLANTED: (B)(6) 2012. A 1688TC COMPETITOR IMPLANTABLE PACING LEAD, IMPLANTED (B)(6) 2005.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4). THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY CUT BUT NOT BREACHED, THE OUTER INSULATION OF THE LEAD DEVELOPED A COSMETIC DEPRESSION WHILE IN VIVO, AND THE OUTER INSULATION OF THE LEAD DEVELOPED COSMETIC ESC (ENVIRONMENTAL STRESS CRACKING) WHILE IN VIVO. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. VISUAL SUMMARY ANALYSIS OF THE LEAD WAS PERFORMED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A FUNERAL HOME. THE CAUSE OF DEATH WAS UNKNOWN. FURTHER REVIEW OF THE MANUFACTURER¿S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY SIX MONTHS POST IPG IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244511 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4568-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Death