BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3940319 · Received July 17, 2014

    Report

    Report Number
    3007566237-2014-01986
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A IMPLANTABLE NEUROSTIMULATOR (INS) DEVICE THAT STARTED HEATING UP AFTER 20 MINUTES. UNABLE TO FOLLOW UP WITH THE CONTACT INFORMATION PROVIDED, HENCE NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420421 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1