BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBD

    MDR report key: 2354901 · Received December 1, 2011

    Report

    Report Number
    3004209178-2011-09522
    Event Type
    Malfunction
    Date Received
    December 1, 2011
    Report Date
    November 9, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 377845, LOT # V003667, IMPLANTED: (B)(6) 2006, EXPLANTED:NA; LEAD MODEL 377745, LOT # N0038947, IMPLANTED: (B)(6) 2006, EXPLANTED:NA; EXTENSION MODEL 3708140, LOT # NJB003476V, IMPLANTED: (B)(6) 2006, EXPLANTED:NA; EXTENSION MODEL 3708140, LOT # NJB003025V, IMPLANTED: (B)(6) 2006, EXPLANTED:NA; PROGRAMMER MODEL 37742, LOT # NJD048772N.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, BEGINNING ABOUT ONE WEEK PRIOR, THE PATIENT FELT THE STIMULATION FROM THE IMPLANTABLE NEUROSTIMULATOR IN THE LEGS INSTEAD OF THE INTENDED LOCATION - THE BACK. THE PATIENT ALSO HAD A RETURN OF BACK PAIN. THERE WAS NO KNOWN RELATED INCIDENT OR ACCIDENT REPORTED, AT THIS TIME. THE PATIENT DID NOT HAVE A GROUP ROW. IT WAS LATER REPORTED THAT THE PATIENT MET WITH THE MANUFACTURER REPRESENTATIVE ON (B)(6) 2011, FOR A REPROGRAMMING SESSION. IT WAS NOT POSSIBLE, AT THAT TIME, TO ISOLATE CENTER-LOW BACK STIMULATION COVERAGE. IT WAS DISCOVERED THAT THE PATIENT HAD A FALL APPROXIMATELY TWO WEEKS PRIOR. X-RAYS OF THE LEAD POSITION WERE ORDERED BY THE PATIENT'S PHYSICIAN, BUT THERE WERE NO RESULTS REPORTED. NO INFORMATION WAS PROVIDED RELATED TO THE PATIENT'S OUTCOME. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TBD STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1