BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2802009 · Received October 23, 2012

    Report

    Report Number
    3004209178-2012-09451
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    September 25, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 39565-30 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708160 LOT# SERIAL# (B)(4),V IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3708160 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WAS UNABLE TO ADJUST STIMULATION. IT WAS ALSO REPORTED, THE PATIENT WAS CHARGING MORE THAN EXPECTED. THE PATIENT HAD A DIAGNOSTIC ULTRASOUND IN (B)(6) 2012 AND SINCE IT HAD SEEMED LIKE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS DEPLETING QUICKER. THE PATIENT HAD AN APPOINTMENT THE NEXT DAY TO HAVE THE DEVICE CHECKED. 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
    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