BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 1260068 · Received December 10, 2008

    Report

    Report Number
    2182207-2008-08173
    Event Type
    Injury
    Date Received
    December 10, 2008
    Report Date
    November 12, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: LARKIN TM, DRAGOVICH A, COHEN SP. ACUTE RENAL FAILURE DURING A TRIAL OF SPINAL CORD STIMULATION: THEORIES AS TO A POSSIBLE CONNECTION. PAIN PHYSICIAN. 2008;11(5):681-686. THIS IS THE FIRST CASE DESCRIBING AN EPISODE OF ACUTE RENAL FAILURE OCCURRING DURING A SPINAL CORD STIMULATION TRIAL. ALTHOUGH ONE CANNOT RULE OUT COINCIDENCE, THE TIMING OF THE OCCURRENCE MAKES IT CONCEIVABLE THAT OUR PATIENT'S ARF DEVELOPED FROM A CONFLUENCE OF EVENTS CONCLUDING WITH SCS. REPORTABLE EVENT: A MALE WITH A HISTORY OF HYPERTENSION AND 3 PRIOR FAILED SPINE SURGERIES, FBSS, UNDERWENT A TRIAL OF SPINAL CORD STIMULATION FOR UNCONTROLLED BILATERAL LOWER EXTREMITY NEUROPATHIC PAIN. TWO DAYS AFTER THE PLACEMENT OF THE PERCUTANEOUS STIMULATOR LEAD, THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF 3 SYNCOPAL EPISODES. HE WAS FOUND TO BE HYPOTENSIVE AND IN ACUTE RENAL FAILURE. THE STIMULATOR WAS REMOVED. AFTER INFUSION OF 3 LITERS OF RINGER'S LACTATE, HIS HEART RATE AND BLOOD PRESSURE IMPROVED AND HE WAS ABLE TO PRODUCE URINE. BY DISCHARGE, 2 DAYS LATER, HIS CREATININE DECREASED TO 1.0MG/DL, HIS BLOOD UREA NITROGEN WAS 23MG/DL, AND HE WAS VOIDING SPONTANEOUSLY.

    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 48 YR Life Threatening LEAD: MODEL UNK N=1| PROGRAMMER: MODEL UNK N=1| EXTENSION: MODEL UNK N=1