BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3112986 · Received May 15, 2013

    Report

    Report Number
    3004209178-2013-07676
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Report Date
    April 24, 2013
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37746 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 3778-75 LOT# SERIAL# (B)(4), PRODUCT TYPE LEAD PRODUCT ID 3778-75 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A JOLT WHEN HE WAS IN CERTAIN POSITIONS. HIS DEVICE WAS GOING TO BE REPROGRAMMED TO FIX IT. HE ALSO LOST STIMULATION TODAY AND RECEIVED THE RECHARGE INS ICON. HE LAST RECHARGED TWO WEEKS AGO. IT WAS NOTED THAT THE STIMULATION HELPS A LOT WITH THE PAIN. AN INFORMATION REQUEST WAS MADE ON THE RECHARGER AND PATIENT PROGRAMMER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE BATTERY IN THE IMPLANTABLE NEUROSTIMULATOR HAD BEEN DEPLETED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215488 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1