BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2833471 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10293
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 18, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 377860 LOT# V017801, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3778-45 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 377760 LOT# V016987, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 37702 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID, 3708160 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN ESTIMATED REPLACEMENT INDICATOR (ERI) MESSAGE. IT WAS ALSO REPORTED, THE PATIENT WAS FEELING STIMULATION BUT "OFF AND ON." ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE PATIENT HAD A BILATERAL SYSTEM AND IT WAS UNKNOWN TO WHICH STIMULATOR THE EVENT PERTAINED, SO A REPORT HAS BEEN FILED ON BOTH. REFER TO MANUFACTURER REPORT #3004209178-2012-10291.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1