BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE LEAD

    MDR report key: 2201542 · Received August 4, 2011

    Report

    Report Number
    1627487-2011-08014
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    DEVICE 2 OF 2; REFERENCE MFR REPORT: 1627487-2011-08013. THE PT RECEIVED A SCS SYS ON (B)(6) 2008. IT WAS REPORTED THAT THE PT HAD BEEN FEELING AN INCREASED STIMULATION ON HER LEFT SIDE WHEN SHE MOVED IN CERTAIN WAYS. THE DEVICE IS STILL IN USE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 116234

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR SCS IPG: MODEL 3788| IMPLANTED:| SCS LEAD ANCHOR: MODEL 1194| IMPLANTED: