BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 10111680 · Received June 2, 2020

    Report

    Report Number
    3004209178-2020-09569
    Event Type
    Injury
    Date Received
    June 2, 2020
    Report Date
    June 2, 2020
    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
    DE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3550-29, LOT# N142746, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3778-60, SERIAL/LOT #: (B)(4), UBD: 21-FEB-2012, UDI#: (B)(4); PRODUCT ID: 3550-29, SERIAL/LOT #: (B)(4), UBD: 22-FEB-2012, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE PATIENT MENTIONED THAT THE REASON WHY THEIR PAIN STIM DEVICE/WHOLE SYSTEM WAS REMOVED WAS BECAUSE IT WAS NOT HELPING AND NOT PROPERLY WORKING. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572458 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