BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL EXTENSION

    MDR report key: 2821127 · Received October 25, 2012

    Report

    Report Number
    1627487-2012-12388
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    August 24, 2012
    Report Date
    October 5, 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

    ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. 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 NUMBER: 1627487-2012-12386 AND 1627487-2012-12387. THE PT REPORTED THE STIMULATION TURNS OFF AND CANNOT BE RESTARTED. THE SJM REP INTERROGATED THE SYSTEM AND FOUND HIGH IMPEDANCES. FURTHER FOLLOW UP DETERMINED THE PHYSICIAN EXPLANTED AND IMPLANTED A NEW IPG, THREE LEADS AND ONE EXTENSION. POST-OPERATIVE PROGRAMMING PROVIDED OPTIMAL PAIN COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL EXTENSION SCS EXTENSION LGW ST. JUDE MEDICAL NEUROMODULATION 3341 3542633

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| SCS LEAD: MODEL 3166| IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)| SCS LEAD: MODEL 3163| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE: