BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2625209 · Received June 21, 2012

    Report

    Report Number
    3004209178-2012-04742
    Event Type
    Injury
    Date Received
    June 21, 2012
    Report Date
    May 25, 2012
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID (B)(4), LOT#, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED:, PRODUCT TYP: LEAD. PRODUCT ID (B)(4), LOT#, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED:, PRODUCT TYP: RECHARGER. PRODUCT ID (B)(4), LOT#, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED:, PRODUCT TYP: PROGRAMMER, PATIENT PRODUCT ID (B)(4), LOT#, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED:, PRODUCT TYP: EXTENSION, PRODUCT ID (B)(4), LOT# V070245, SERIAL#, IMPLANTED: (B)(6) 2008, EXPLANTED:, PRODUCT TYP: LEAD. PRODUCT ID (B)(4), LOT# V070245, SERIAL#, IMPLANTED: (B)(6) 2008, EXPLANTED:, PRODUCT TYP: LEAD. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS NOT REQUIRED TO INITIATE ANY REMEDIAL ACTIONS TO PREVENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NOT USED THE INTERNAL NEUROSTIMULATOR (INS) FOR THREE YEARS AND HAD IT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 PRODUCT ID (B)(4) LOT# SERIAL# (B)(4)