BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4595208 · Received March 12, 2015

    Report

    Report Number
    3004209178-2015-04624
    Event Type
    Injury
    Date Received
    March 12, 2015
    Report Date
    February 17, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3986A, LOT# N140013, IMPLANTED: 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A COUPLING PROBLEM, THE PATIENT WAS RECHARGING WAS UNABLE TO GET MORE THAN TWO COUPLING BARS. THE POCKET WAS TILTED AS WELL. THE PATIENT TOOK SEVERAL DAYS TO GET FULLY CHARGED. A POSSIBLE FLIP, POCKET REVISION WAS DISCUSSED. THE PATIENT HAD BEEN A HIGH ENERGY USER AROUND 7.5V BUT THE REPROGRAMMING HAD PUT HER DOWN TO 5V. THE PATIENT HAD BEEN HAVING THIS ISSUE ABOUT A YEAR AND BEEN A GRADUAL ISSUE. THE PATIENT HAD LOST AND GAINED WEIGHT CAUSING DEVICE TO SHIFT A LITTLE. IT WAS NOT DEVICE RELATED. THE PATIENT WAS STILL ONLY GETTING TWO BARS. EIGHTEEN MONTHS UNTIL END OF SERVICE (EOS) AND THE PHYSICIAN WAS OPTING TO REPLACE. THE PATIENT HAD GOOD THERAPY. THE REPLACEMENT WAS TO BE SCHEDULED WITHIN THE NEXT FEW WEEKS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172576 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 Required Intervention