BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIPOLE 16 LEAD

    MDR report key: 2201549 · Received August 4, 2011

    Report

    Report Number
    1627487-2011-08012
    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
    TX, 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

    THE PATIENT RECEIVED A SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT HAD BEEN FEELING NUMBNESS 4-5 INCHES ABOVE HER FOOT WHEN THE THERAPY WAS TURNED OFF OR ON. THE PATIENT CONFIRMED THE STIMULATION WAS TURNED OFF. THE DEVICE IS STILL IN USE. UPON FOLLOW-UP WITH THE PATIENT ON (B)(6) 2010, PATIENT INDICATED THAT HER SYMPTOMS OF NUMBNESS HAD NOT RESOLVED AND ALLEGED THAT HER SYMPTOMS WERE NOT RELATED TO THE SCS SYSTEM OR THE THERAPY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIPOLE 16 LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3229447

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR SCS IPG: MODEL 3788| IMPLANT: