BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX

    MDR report key: 3000515 · Received March 12, 2013

    Report

    Report Number
    2649622-2013-02522
    Event Type
    Death
    Date Received
    March 12, 2013
    Date of Event
    January 25, 2013
    Report Date
    March 29, 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED. ADDRS1 IMPLANTABLE PULSE GENERATOR, (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A DUAL CHAMBER IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A FUNERAL HOME WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY ONE MONTH POST THE IPG IMPLANT.

    Description of Event or Problem · 1

    A DUAL CHAMBER IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A FUNERAL HOME WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY ONE MONTH POST THE IPG IMPLANT. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103334 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5568-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Death (B)(4) IMPLANTABLE PACING LEAD