BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4854118 · Received June 18, 2015

    Report

    Report Number
    3004209178-2015-11878
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    February 1, 2015
    Report Date
    May 29, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377660, LOT# V002687, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A COMMUNICATION PROBLEM. THE PATIENT COULD NOT CONNECT WITH THE RECHARGER. AN IMPLANTABLE NEUROSTIMULATOR (INS) OVERDISCHARGE WAS SUSPECTED. THE PATIENT HAD NOT FELT STIMULATION IN 2 WEEKS. THE PATIENT REPORTED THAT THEY LOST 25 POUNDS IN THE PAST 3 MONTHS. THE PATIENT STATED THAT SHE COULD NOT SLEEP. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS MOVING IN THE POCKET. THE PATIENT WAS GOING TO MEET THE DOCTOR ON (B)(6) 2015. THE PATIENT MOVED 3 WEEKS PRIOR TO REPORT. THE PATIENT¿S SON IN LAW PACKED THE CHARGER UNIT IN A SEPARATE BOX WITHOUT THE PATIENT¿S KNOWLEDGE AND THEY RECENTLY FOUND IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398602 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR