BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 5507301 · Received March 17, 2016

    Report

    Report Number
    3004209178-2016-04776
    Event Type
    Injury
    Date Received
    March 17, 2016
    Report Date
    February 23, 2016
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888-56, LOT# V433259, PRODUCT TYPE: LEAD. PRODUCT ID 3888-56, LOT# V433259, PRODUCT TYPE: LEAD. PRODUCT ID 3888-45, LOT# V760959, PRODUCT TYPE: LEAD. PRODUCT ID 3888-45, LOT# V760959, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL PAIN AND POST LUMBAR LAMINECTOMY SYNDROME. IT WAS REPORTED THAT THE PATIENT HAD A PERIPHERAL SYSTEM IMPLANTED FOR SEVERAL YEARS. THE SYSTEM WAS REPLACED ON (B)(6) 2016 DUE TO END OF SERVICE (EOS) AND THE ¿LEADS BURNING OUT.¿ THERE WERE NO SYMPTOMS KNOWN AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING CLARIFICATION ON THE EOS AND LEADS BURNING OUT, SYMPTOMS, CAUSE, ACTIONS AND INTERVENTIONS, AND DEVICE LOCATION FOR ANALYSIS, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163323 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 Required Intervention