BEUDAMED
    FDA Adverse Event Death Summary report: N

    8-CHANNEL ADAPTER, MDT, 10CM

    MDR report key: 6951690 · Received October 16, 2017

    Report

    Report Number
    1627487-2017-06134
    Event Type
    Death
    Date Received
    October 16, 2017
    Date of Event
    September 15, 2017
    Report Date
    October 16, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    DEVICE 3 OF 3. REFERENCE MFR. REPORT#: 1627487-2017-06132. REFERENCE MFR. REPORT#: 1627487-2017-06133. IT WAS REPORTED THE PATIENT PASSED AWAY ON (B)(6) 2017 (ACCORDING TO OBITUARY) DUE TO HEART ATTACK. THE DEATH WAS UNRELATED TO ABBOTT PRODUCTS. IT IS UNKNOWN IF DEATH WAS RELATED TO THE PROCEDURE. IT WAS REPORTED THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2017 TO IMPLANT ABBOTT/SJM PRODUCTS. HOWEVER, THE PROCEDURE WAS ABANDONED (REFERENCE MFR. REPORT#'S : 1627487-2017-05847, REFERENCE MFR. REPORT#: 1627487-2017-05848 , AND REFERENCE MFR. REPORT#: 1627487-2017-05850). THE PATIENT PREVIOUSLY HAD A COMPETITOR'S SYSTEM. IT WAS NOTED THE COMPETITOR'S IPG WAS EXPLANTED ON (B)(6) 2017, BUT THE COMPETITOR'S LEADS REMAINED. NO ABBOTT PRODUCTS WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731867 8-CHANNEL ADAPTER, MDT, 10CM SCS ADAPTER GZB ST. JUDE MEDICAL - NEUROMODULATION 2311 5975487

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death