BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4726660 · Received April 24, 2015

    Report

    Report Number
    3004209178-2015-07842
    Event Type
    Malfunction
    Date Received
    April 24, 2015
    Report Date
    March 31, 2015
    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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 377875, LOT# V003909, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 355029, LOT# N063026, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO CHARGE THE IMPLANTABLE NEUROSTIMULATOR (INS). THEY COULD NOT FEEL STIMULATION AND THEY HAD CHARGED IMPLANT FOR 4-5 HOURS AND THE PATIENT PROGRAMMER WAS SHOWING THAT THE INS WAS EMPTY. THE PATIENT TRIED TO CHARGE AGAIN AND WAS GETTING ELECTIVE REPLACEMENT INDICATOR (ERI) ON THE RECHARGER SCREEN. THE PATIENT WAS ABLE TO GET ALL EIGHT BARS AND THE INS WAS CHARGING. THE INS WAS SHOWING ¾ CHARGE ON THE SCREEN AND THE THERAPY ICON WAS ON. THE PATIENT HAD AN APPOINTMENT WITH THEIR HEALTH CARE PROFESSIONAL FOR (B)(6) 2015. WHEN THEY MOVED THE BELT AWAY FROM THEIR IMPLANT THE INS LEVEL SHOWED EMPTY. ON (B)(6) 2015 ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT HAD LOW BACK AND LEG PAIN. IT WAS UNKNOWN IF THE DEVICE WOULD BE EXPLANTED OR REPLACED. THE PATIENT DEVICE WAS NOT FUNCTIONING. THE PATIENT¿S ISSUES/SYMPTOMS WERE STILL ONGOING. THE PATIENT WAS EXPERIENCING LOW BACK AND LEG PAIN DUE TO THE INS NOT HOLDING CHARGE, WHEN THE INS WAS FUNCTION THEY FOUND IT BENEFICIAL. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272601 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR