BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 2886415 · Received December 26, 2012

    Report

    Report Number
    3007566237-2012-03115
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 387360, LOT# V991497. PRODUCT TYPE: SCREENING DEVICE: PRODUCT ID 387360, LOT# V710989. PRODUCT TYPE: SCREENING DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE TRIAL LEAD PULL APPOINTMENT, THE PATIENT WAS COMPLAINING OF VOMITING AND DIZZINESS. NO DRAINAGE, FLUID OR REDNESS WAS REPORTED. THE PATIENT WAS HOSPITALIZED FOR THE PREVIOUS SYMPTOMS. BRADYCARDIA AND ALTERED MENTAL STATUS WERE ALSO NOTED IN RELATION TO THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization