BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 2230811 · Received August 23, 2011

    Report

    Report Number
    1627487-2011-07105
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 21, 2011
    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

    THE PT RECEIVED A SCS SYSTEM AND ON (B)(6) 2011, IT WAS REPORTED THAT THE PT HAD STIMULATION BUT WAS BROUGHT IN FOR SURGERY TO REPLACE A NON-FUNCTIONING LEAD. DIAGNOSTIC TESTING SHOWED THE LEAD WAS FRACTURED AND GAVE INVALID RESULTS. THE DOCTOR REPLACED ONLY ONE OF THE PT'S LEADS, THE OTHER LEAD WAS REPOSITIONED. THE EXPLANTED LEAD WILL NOT BE RETURNED AND THE LOT AND MODEL NUMBER FOR THE EXPLANTED LEAD IS UNK. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention