BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3240220 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12076
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 26, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A LEAD REVISION BECAUSE THE PATIENT HAD A CAR ACCIDENT AND FELT SHOCKING WHEN THEY WOULD TURN STIMULATION ON.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THERE WAS NO APPARENT CAUSE FOR THE SHOCKING. IT WAS NOTED THAT HIGH IMPEDANCES WERE SEEN ON MULTIPLE ELECTRODES. FOLLOWING THE REVISION, THE PATIENT¿S CONCERNS WERE RESOLVED AND THAT THE MANUFACTURER¿S REPRESENTATIVE HAD NOT BEEN CONTACTED BY THE PATIENT SINCE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339643 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention