BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3833258 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09630
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    May 5, 2014
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377875, LOT# V014605, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 377875, LOT# V014605, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REMOVED ON (B)(6) 2012 BECAUSE IT WAS NON-FUNCTIONING. IT WAS UNKNOWN WHEN THE INS STOPPED FUNCTIONING. THE CAPSULE WAS OPENED AND THE INS WAS RETRIEVED WITHOUT DIFFICULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE EPIDURAL INS IMPLANT WAS SUCCESSFUL FOR SEVERAL YEARS BUT AT SOME POINT THE PATIENT FORGOT TO CHARGE THE INS. AFTER THAT IT WOULD NOT APPEAR TO BE USEFUL IN RELIEVING PAIN. THE PATIENT HAD NOT USED THEIR DEVICE IN SEVERAL MONTHS BEFORE THE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310876 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 Required Intervention