BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 3032601 · Received April 3, 2013

    Report

    Report Number
    2649622-2013-02592
    Event Type
    Death
    Date Received
    April 3, 2013
    Date of Event
    November 2, 2012
    Report Date
    April 8, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #EVALUATION SUMMARY: THE LEAD WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED WITH NO INFORMATION . A SEARCH BY SERIAL NUMBER REVEALED THE PATIENT TO BE DECEASED. THE DEATH OCCURED LESS THAN ONE YEAR AFTER IMPLANT. FOLLOW UP FOR INFORMATION WAS INCONCLUSIVE. NO SPECIFIC COMPLAINTS HAVE BEEN MADE AGAINST THE DEVICE SYSTEM. FURTHER INFORMATION WAS REQUESTED AND NOT YET MADE AVAILABLE.

    Description of Event or Problem · 1

    THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED WITH NO INFORMATION . A SEARCH BY SERIAL NUMBER REVEALED THE PATIENT TO BE DECEASED. THE DEATH OCCURRED LESS THAN ONE YEAR AFTER IMPLANT. FOLLOW UP FOR INFORMATION WAS INCONCLUSIVE. NO SPECIFIC COMPLAINTS HAVE BEEN MADE AGAINST THE DEVICE SYSTEM. FURTHER INFORMATION WAS REQUESTED AND NOT YET MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135780 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407452

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Death