BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2212598 · Received August 11, 2011

    Report

    Report Number
    3007566237-2011-06264
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 EXPERIENCED A RETURN OF SYMPTOMS. IMPEDENCE MEASUREMENTS CONFIRMED THE BREAK OF THE LEAD WITH READINGS GREATER THAN 4,000 OHMS. THERE WAS ONLY ONE BIPOLAR CONFIGURATION THAT MADE THE PT FEEL THE STIMULATION. HOWEVER, THIS CONFIGURATION PROVIDED NO EFFICACY. THE LEAD WAS REMOVED AND REPLACED. AT THE TIME OF EXPLANTATION, IT WAS NOTICED THAT THE LEAD HAD BROKEN AT THE LEVEL OF ONE OF THE ELECTRODES. THERE WAS NO INJURY TO THE PT AND THE PT'S OUTCOME WAS NOTED TO BE "OK." A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention EXPLANTED:| LEAD: MODEL 3889, LOT # UNK| IMPLANTED: