BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 10303146 · Received July 21, 2020

    Report

    Report Number
    3004209178-2020-12553
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    July 17, 2020
    Report Date
    July 24, 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
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 377775, LOT#: V012668, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID: 3777-75, SERIAL#:(B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 377775, SERIAL/LOT #: (B)(4), UBD: 22-SEP-2010, UDI#:(B)(4) ; PRODUCT ID: 3777-75, SERIAL/LOT #: (B)(4), UBD: 18-SEP-2011, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 377775, LOT# V012668, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID: 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE REPORTED THAT THEY WERE REPLACING THE IMPLANT DUE TO ROUTINE END OF SERVICE AND FOUND THAT IMPEDANCES WERE HIGH ON CONTACT 15. THE LEADS WERE FOUND TO BE FRACTURED SO BOTH WERE REPLACED. IT WAS NOTED THAT THE PATIENT WAS GETTING GOOD STIMULATION UP UNTIL THEIR IMPLANT DIED DUE TO NORMAL END OF SERVICE. NO PATIENT SYMPTOMS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP). THE CAUSE OF THE EVENT WASN¿T DETERMINED, THE LEAD WAS OVER 10 YEARS OLD. THE SYSTEM WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766853 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention