BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3293538 · Received August 16, 2013

    Report

    Report Number
    3004209178-2013-14744
    Event Type
    Malfunction
    Date Received
    August 16, 2013
    Report Date
    July 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID 377660, LOT# V001920, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POWER ON RESET (POR) CONDITION. IT WAS UNKNOWN IF THE POR WAS SHOWING UP ON THE PATIENT PROGRAMMER. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397399 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR