BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 3192842 · Received June 27, 2013

    Report

    Report Number
    3007566237-2013-02130
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 6, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE LEAD REVEALED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PADDLE LEAD THAT WAS IMPLANTED FOR THE TRIAL DID NOT PROVIDE ANY STIMULATION FEELING TO THE PATIENT. THE PHYSICIAN PLACED A NEW LEAD AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    UPON FURTHER REVIEW, IT WAS NOTED THAT THERE WAS A DUPLICATE REPORT. MFR 3007566237-2013-02169 CONTAINS THE DUPLICATE INFORMATION. ALL ONGOING EVENT INFORMATION WILL BE REPORTED UNDER 3007566237-2013-02130.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292010 UNKNOWN EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1