BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2863409 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11328
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 11, 2012
    Report Date
    November 13, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 377760 LOT# N0047650, IMPLANTED: 2005 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 377760 LOT# N0047655, IMPLANTED: 2005 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXHIBITED ACUTE PAIN AFTER HIS HAND CAME IN CONTACT WITH A TASER. IT WAS STATED THAT THE CONTACT WAS FOR FIVE SECONDS AND WAS AT 50,000 VOLTS. THE PATIENT HAD THE DEVICE TURNED OFF SINCE THE DAY OF THE EVENT; HOWEVER, HE DIDN'T NORMALLY USE THE STIMULATOR. IT WAS NOTED THAT THE DEVICE WORKED WELL UNTIL THEN. THE PATIENT HAD AN APPOINTMENT SCHEDULED WITH A HEALTH-CARE PROFESSIONAL. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 00041 YR