BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2582171 · Received May 21, 2012

    Report

    Report Number
    3004209178-2012-03536
    Event Type
    Injury
    Date Received
    May 21, 2012
    Report Date
    April 26, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377860, LOT# V001918, SERIAL# IMPLANTED: (B)(6) 2006, EXPLANTED: PRODUCT TYP LEAD PRODUCT ID 377860, LOT# V001918, SERIAL# IMPLANTED: (B)(6) 2006, EXPLANTED: PRODUCT TYP LEAD PRODUCT ID 37742, LOT# SERIAL# (B)(4), IMPLANTED: (B)(4) 2006, EXPLANTED: PRODUCT TYP PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S STIMULATION DEVICE WAS REMOVED "BECAUSE IT HAD A SHORT AND IT KEPT CUTTING IN AND OUT." IT WAS ALSO REPORTED THE PATIENT WAS IN A CAR ACCIDENT AT SOME POINT, BUT IT WAS UNCLEAR IF THIS OCCURRED PRIOR TO IMPLANT OR THE REASON FOR ITS REMOVAL. THE PATIENT NOW HAS A PUMP DEVICE, AND IS VERY PLEASED THE PAIN RELIEF. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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