BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION, DUAL 4 CHANNEL 20CM

    MDR report key: 2092676 · Received May 10, 2011

    Report

    Report Number
    1627487-2011-00638
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 6 OF 6. REFERENCE MFR. REPORT #S 1627487-2011-00633, 1627487-2011-00634, 1627487-2011-00635, 1627487-2011-00636 AND 1627487-2011-00637.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION, DUAL 4 CHANNEL 20CM SPINAL CORD STIMULATION LEAD EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3342 R83997

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention SCS IPG, MODEL: 3716| IMPLANT DATE: