BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2842445 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10642
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 37092 LOT# 272450001, IMPLANTED: 2011 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 355531 LOT# N276853, IMPLANTED: 2011 (B)(6), PRODUCT TYPE SCREENING DEVICE PRODUCT ID, 3550-39 LOT# N278574, IMPLANTED: 2011 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED NO STIMULATION SENSATION. IT WAS NOTED THAT THE PATIENT WAS IN A CAR ACCIDENT IN (B)(6) AND THAT THE STIMULATION STOPPED WORKING AFTER THAT. AN X-RAY CONFIRMED THAT A LEAD HAD BROKEN. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1