BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTERNAL NERUOSTIMULATOR

    MDR report key: 2943949 · Received February 5, 2013

    Report

    Report Number
    3007566237-2013-00371
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-60, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP REPORTED THAT THE TRIAL WAS REMOVED AND THAT THE PATIENT DID NOT GO ON TO THE PERMANENT IMPLANT PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TRIAL DONE AND ENDED UP IN EMERGENCY ROOM (ER) THAT NIGHT FOR EXTREME BLEEDING. ER DOCTOR SAID TRAILING PHYSICIAN HIT A VEIN DURING TRIAL. THE PATIENT WAS HOSPITALIZED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS UNAVAILABLE AT THE DATE OF THIS REPORT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47952 UNKNOWN EXTERNAL NERUOSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R