BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 4779053 · Received May 18, 2015

    Report

    Report Number
    3004209178-2015-09322
    Event Type
    Malfunction
    Date Received
    May 18, 2015
    Report Date
    April 27, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3487A-56, LOT# V594725, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# V999674, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-33, LOT# VA03DT1, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-56, LOT# V974781, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STIMULATOR WOULD NOT DO ANYTHING AND IT SHOWED THAT IT WAS CHARGED ON THE RECHARGER SCREEN AND PATIENT PROGRAMMER SCREEN SHOWED A DEAD BATTERY AND THE PATIENT PROGRAMMER BATTERIES WERE REPLACED. THE PATIENT CHARGED THEIR IMPLANT ABOUT A WEEK AGO AND SOMETIMES THEY SAW THE CODE 7.1 BUT NOT SURE WHAT IT WAS. THE PATIENT RECEIVED ASSISTANCE ON USING THE PROGRAMMER TO SYNC TO THE IMPLANT AND THE PROGRAMMER SCREEN SHOWED RECHARGE IMPLANT ICON ON THE SCREEN. THE PATIENT WAS ASSISTED ON USING THE RECHARGER AND THE SCREEN SHOWED ALL COUPLING BARS AND THE STIMULATOR LESS THAN ¼ CHARGE. IT WAS THOUGHT THAT THEY MAY HAVE NOT CHARGE THEIR IMPLANT AS MUCH AS IT WAS THOUGHT. THERE WAS A NOTE ABOUT CONFUSING COUPLING BARS WITH THE STIMULATOR CHARGE LEVEL. ON MAY 12TH 2015 ADDITIONAL INFORMATION WAS RECEIVED REGARDING A PROBLEM WITH THE PATIENT PROGRAMMER. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323797 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR