BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST JUDE MEDICAL ABBOTT NEUROSTIMULATOR TRIAL WITH LUMBAR BURST

    MDR report key: 8949682 · Received August 29, 2019

    Report

    Report Number
    MW5089462
    Event Type
    Injury
    Date Received
    August 29, 2019
    Date of Event
    March 21, 2019
    Report Date
    August 25, 2019
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A (B)(6) TRIAL ON 03/21/2019, HOWEVER, WHEN PT WOKE UP FROM PROCEDURE AND WAS IN RECOVERY ROOM, PT REPORTED TO NURSE SEVERE NUMBNESS AND HEAVINESS IN BOTH LOWER EXTREMITIES AND UNABLE TO MOVE LEGS. THE LEADS HAD BEEN REMOVED DUE TO SEVERE NUMBNESS AND HEAVINESS IN PT'S BILATERAL LOWER EXTREMITIES. PT HAD BEEN SENT TO THE HOSP EMERGENCY ROOM AND HAD BEEN ADMITTED FOR APPROX 7 DAYS. PT HAS BEEN DIAGNOSED WITH PARALYSIS AND LEFT FOOT DROP, CHRONIC NERVE PAIN, PERONEAL NERVE DAMAGE, NUMBNESS TO RIGHT LOWER EXTREMITY, AND WEAKNESS TO BOTH LOWER EXTREMITIES. TWO DEVICES: SERIAL NUMBERS (B)(4), REF 3086 OCTRODE SJM (01) 05414734401555(17) 210219 (21) 17965073 EXP 02/19/2021; (01) 05414734401555 (17) 210213 (21) 17955918 EXP 02/13/2021. ABBOTT REP NAME - (B)(6) PRESENT IN OPERATORY SURGERY ROOM AND IN RECOVERY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741867 ST JUDE MEDICAL ABBOTT NEUROSTIMULATOR TRIAL WITH LUMBAR BURST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF GZB ABBOTT MEDICAL 3086 (01)05414734401555
    741868 ST JUDE MEDICAL ABBOTT NEUROSTIMULATOR TRIAL WITH LUMBAR BURST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF GZB ABBOTT MEDICAL 3086 (17) 210219 (21) 17965073

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| O| S