BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 5091018 · Received September 21, 2015

    Report

    Report Number
    3004209178-2015-18314
    Event Type
    Injury
    Date Received
    September 21, 2015
    Report Date
    August 27, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3774,3 SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT AFTER SEVEN YEARS OF IT BEING PUT IN, THE PATIENT ONLY HAD TO CHARGE IT ONE TIME A WEEK. BEFORE IT WAS TAKEN OUT AND REPLACED, THE PATIENT HAD TO CHARGE IT AT LEAST THREE TIMES A WEEK.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THE BATTERY WAS REPLACED DUE TO THE IMPLANTABLE NEUROSTIMULATOR (INS) NOT HOLDING A CHARGE. IT WAS NOTED THE PATIENT HAD TO CHARGE IT AT LEAST THREE OR FOUR TIMES A WEEK AND THE INS HAD BEEN IN HIS BODY FOR 7.5 YEARS. ON THE MONDAY FOLLOWING THE REPORT, THE PATIENT HAD AN APPOINTMENT TO CHECK ON THE HEALING PROCESS OF THE INCISION. RELEVANT MEDICAL HISTORY INCLUDED POST LUMBAR LAMINECTOMY SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621836 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 Required Intervention