BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBRAXP PULSE GENERATOR, DUAL 4-CHANNEL

    MDR report key: 4898458 · Received July 8, 2015

    Report

    Report Number
    1627487-2015-26284
    Event Type
    Death
    Date Received
    July 8, 2015
    Date of Event
    June 25, 2015
    Report Date
    June 25, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    MHY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO IMPLANT A DBS SYSTEM. THE NEXT DAY, THE PATIENT SUFFERED A SEPTAL MYOCARDIAL INFARCTION, RESUSCITATION WAS UNSUCCESSFUL AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441825 LIBRAXP PULSE GENERATOR, DUAL 4-CHANNEL DBS IPG MHY ST. JUDE MEDICAL - NEUROMODULATION 6644 4904728

    Patients

    Seq Age Sex Outcome Treatment
    1 Death MODEL 6149 (2), DBS LEAD| MODEL 6316 (2), DBS EXTENSION