BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44, 60 CM

    MDR report key: 2220241 · Received August 16, 2011

    Report

    Report Number
    1627487-2011-07074
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT 1627487-2011-07053. THE PATIENT RECEIVED A SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED ON (B)(6) 2011 THAT THE PATIENT HAS NOT USED THE SCS SYSTEM FOR A FEW MONTHS. THE PATIENT IS EXPERIENCING STIMULATION IN THE WRONG AREA AND IS UNABLE TO SHUT THE STIMULATION OFF. THE PATIENT ALSO REPORTED THAT SHE CANNOT RECHARGE THE IPG DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44, 60 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 117925

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention SCS LEAD: MODEL 3244| IMPLANT DATE: