BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 6086141 · Received November 8, 2016

    Report

    Report Number
    1627487-2016-05785
    Event Type
    Death
    Date Received
    November 8, 2016
    Date of Event
    October 8, 2016
    Report Date
    October 16, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2016 WHERE A PERMANENT SCS SYSTEM WAS IMPLANTED. THE PATIENT EXPIRED (B)(6) 2016. THE SCS SYSTEM HAD NOT BEEN TURNED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736579 PENTA 3MM LEAD, 60 CM SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 5614541

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death MODEL 3228, SCS LEAD