BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3832865 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09620
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3550-39, LOT# N335806, IMPLANTED: (B)(6) 2012-07, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE :LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR (INS) SOMETIMES SHUT DOWN ON ITS OWN EVEN THOUGH IT WASN¿T CLOSE TO DEPLETED. IT WAS NOTED THAT THE PROBLEM STARTED WITHIN THE LAST THREE MONTHS AND THE PATIENT CONFIRMED THAT THE LIGHTNING BOLT ICON WAS ABSENT FROM THE PATIENT PROGRAMMER SCREEN EACH TIME THIS OCCURRED. IT WAS LATER REPORTED THAT THERE WERE DIAGNOSTICS PERFORMED AND CONTACT 8 HAD IMPEDANCES OF GREATER THAN 10,000 OHMS. IT WAS NOTED THAT THIS CONTACT WAS NOT BEING USED. IT WAS REPORTED THAT THE PROGRAMS WORKED AND THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS ASSUMED ALL WAS WELL AS THE PATIENT HAD NOT REPORTED BACK AND THE HEALTH CARE PROFESSIONAL HAD NOT REPORTED TO SAY IT WAS NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310806 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 00050 YR