BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 2160746 · Received July 7, 2011

    Report

    Report Number
    1627487-2011-01715
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: VISUAL ANALYSIS OF THE EXTENSION NOTED A BROKEN WIRE ON CHANNEL 8 OF THE EXTENSION HEADER. THE EXTENSION FAILED CONTINUITY AND STRESS TESTING ON CHANNEL 8. 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 2 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-01712. IT WAS REPORTED THAT THE PT (B)(6) LOST STIMULATION WHEN THE PT TOUCHED THE EXTENSION CONNECTOR. THE PHYSICIAN EXPLANTED AND REPLACED BOTH THE PT'S EXTENSIONS ON (B)(6) 2011. THE PT REPORTED EFFECTIVE STIMULATION WAS RECAPTURED POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE EXTENSION SPINAL CORD STIMULATION EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3383 3290707

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention IMPLANT:| SCS IPG, MODEL: 3788