BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION

    MDR report key: 2843493 · Received November 19, 2012

    Report

    Report Number
    1627487-2012-12530
    Event Type
    Injury
    Date Received
    November 19, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 3 OF 3. REFERENCE MFR REPORT: 1627487-2012-12528 AND 1627487-2012-12529. IT WAS REPORTED THE PT EXPERIENCED STIMULATION COVERAGE IN THE ESTABLISHED PAIN PATTERN BUT DID NOT RECEIVE DESIRED PAIN RELIEF. REPORTEDLY THE PT WANTED THE SYSTEM EXPLANTED. NOTE THE PT HAS TWO LEADS WITH THE SAME LOT NUMBER IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SCS EXTENSION LGW ST. JUDE MEDICAL NEUROMODULATION 3383 33410905

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)