BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 11772160 · Received May 4, 2021

    Report

    Report Number
    3004209178-2021-07170
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    January 1, 2011
    Report Date
    May 4, 2021
    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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3487A-56, LOT#: V153177, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3776-60, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT#: V153177, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HEALTHCARE PROVIDER (MRI TECH) THAT THE PATIENT HAD THE IMPLANT REMOVED IN 2011 DUE TO NO LONGER WORKING AND THE PHYSICIAN LEFT THE LEAD INTACT. CALLER ALSO REPORTED THE PATIENT HAD LUMBAR MRI LAST YEAR AND THERE WERE NO REPORTS OF ADVERSE ISSUES. NO PATIENT SYMPTOMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669028 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 40 YR Required Intervention