BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2596276 · Received June 1, 2012

    Report

    Report Number
    3004209178-2012-03953
    Event Type
    Injury
    Date Received
    June 1, 2012
    Report Date
    May 3, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3888-45, LOT# V126618, SERIAL# IMPLANTED: (B)(6) 2008, EXPLANTED: PRODUCT TYP LEAD PRODUCT ID 3888-45, LOT# V111114, SERIAL# IMPLANTED: (B)(6) 2008, EXPLANTED: PRODUCT TYP LEAD PRODUCT ID 3888-45, LOT# V111114, SERIAL# IMPLANTED: (B)(6) 2008, EXPLANTED: PRODUCT TYP LEAD PRODUCT ID 3888-45, LOT# V123646, SERIAL# IMPLANTED: (B)(6) 2008 EXPLANTED: PRODUCT TYP LEAD PRODUCT ID 37752, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: PRODUCT TYP RECHARGER PRODUCT ID 37743 LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: PRODUCT TYP PROGRAMMER, PATIENT PRODUCT ID 37082-20, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: PRODUCT TYP EXTENSION PRODUCT ID 37082-20, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: PRODUCT TYP EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LOST A LOT OF WEIGHT AND HAD TO HAVE THE DEVICE REPLACED BECAUSE IT WAS "FLOPPING AROUND." THE PATIENT ALSO HAD DIFFICULTY CHARGING THE DEVICE (ALSO NOTED AS FORGOT HOW TO CHARGE). THE PATIENT'S DEVICE WAS REPLACED WITH A NON-RECHARGEABLE DEVICE.

    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