BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME

    MDR report key: 2972761 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-02961
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    February 4, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    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: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PRODUCT ID: 3093-28, LOT# V753436, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN FEELING NO STIMULATION SINCE THE BEGINNING OF (B)(6) 2013, AND DENIED ANY FALL OR TRAUMA. IT WAS REVIEWED TO REPROGRAM STIMULATION TO ADDRESS STIMULATION NEEDS. THE ONLY ELECTRODE COMBINATION PAIR THAT WAS NORMAL LIMITS: REFERENCE 4: 1: 1434 OHMS 5: 1261 OHMS 7: 1509 OHMS; REFERENCE 5: 1: 1052 OHMS, 4: 1275 OHMS, 7: 1082 OHMS; AND REFERENCE 7: 1: 1171 OHMS, 4: 1519 OHMS, 5: 1082 OHMS. IT WAS NOTED THAT THE PATIENT WAS ABLE TO FEEL STIMULATION AT 1-4+.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76418 RESTORE PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37701

    Patients

    Seq Age Sex Outcome Treatment
    1