BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2821569 · Received November 6, 2012

    Report

    Report Number
    3004209178-2012-09970
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    October 8, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3550-29, LOT# N167220, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RECHARGING WILL NOT TURN THE DEVICE ON NOR WILL THE PATIENT PROGRAMMER CONNECT WITH THE DEVICE. THE PATIENT WAS LAST ABLE TO CHARGE ABOUT A MONTH AGO. SHE HAD TURNED THE DEVICE OFF FOR THE LAST MONTH OR SO BECAUSE SHE WAS NOT IN PAIN. SHE SAW A FULL BATTERY ON BOTH THE RECHARGER AND THE DEVICE. THE PATIENT HAD LOST 20 LBS. WITHIN THE LAST MONTH AND HALF OR TWO MONTHS, AND FELT THE DEVICE MORE. THE PATIENT'S SON HAD KNOCKED THE DEVICE SEVERAL TIMES WHILE CLIMBING ON HER, AND SHE HAD TALKED TO HER HCP (HEALTH CARE PROFESSIONAL) ABOUT THE DEVICE STICKING OUT FURTHER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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