BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENEW RECEIVER

    MDR report key: 2831889 · Received November 9, 2012

    Report

    Report Number
    1627487-2012-02637
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 15, 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 INFORMATION 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-02638. THE PT REC'D TWO LEADS (FROM THE SAME LOT) IMPLANTED IN THE SACRAL REGION AS PART OF HER SCS SYSTEM. IT WAS REPORTED, THE PT FELT INEFFECTIVE STIMULATION EVEN THOUGH HER STIMULATION COVERAGE HER AREAS OF PAIN. THE PT STATED, SHE WAS VERY HESITANT TO UNDERGO ANOTHER SURGERY BECAUSE, HER IMPLANT PROCEDURE WAS DIFFICULT. IT WAS REPORTED, THE PT AND PHYSICIAN ARE TRYING TO DETERMINE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEW RECEIVER SCS RECEIVER LGW ST. JUDE MEDICAL - NEUROMODULATION 3416 A11720

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention