BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2230570 · Received August 12, 2011

    Report

    Report Number
    9614453-2011-06303
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 19, 2011
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT FELT A SUDDEN "BIG DISCHARGE" THAT WAS "VERY HIGH" FROM THE IMPLANTABLE NEUROSTIMULATOR WHILE DRIVING, AND WAS, THEN, INVOLVED IN A CAR ACCIDENT. THE LOCATION OF THIS SENSATION IN THE PT'S BODY WAS NOT KNOWN. THE DATE OF THIS EVENT WAS NOT KNOWN. THE PT, THEREAFTER, NO LONGER FELT THE STIMULATION AND IMPEDANCE READINGS WERE FOUND TO BE GREATER THAN 10,000 OHMS. SOME REPROGRAMMING OF THE PT'S DEVICE WAS ATTEMPTED. A RADIOGRAPH WAS PERFORMED. THE EXTENSION WAS REMOVED AND REPLACED. THERE WAS NO INJURY TO THE PT. THE PT'S LEAD DID NOT SEEM BE DAMAGED AND WAS LEFT IMPLANTED AT THAT TIME. THE PT'S OUTCOME WAS NOTED TO BE "OK." IT WAS LATER REPORTED THAT AFTER THE REVISION, THE PT COULD NOT FEEL THE STIMULATION. IT WAS NOT KNOWN IF ANY FURTHER INTERVENTION INVOLVING THE PT'S LEAD OCCURRED. A MANUFACTURER REPRESENTATIVE SUBSEQUENTLY MET WITH THE PT AND "EVERYTHING WAS ALRIGHT." THE PT WAS "VERY RELIEVED BY THE STIMULATION," AT THAT TIME. A FOLLOW-UP WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR LGW MEDTRONIC EUROPE SARL 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT # NHU218781V| EXPLANTED:| LEAD: MODEL UNK, LOT # UNK