BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2926918 · Received January 23, 2013

    Report

    Report Number
    3004209178-2013-00882
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Report Date
    January 4, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 377745, LOT# V011529, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 377745, LOT# V011529, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-33, LOT# J0444190V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 3487A-33, LOT# J0504247V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE TELEMETRY ISSUES. AN IMPLANTABLE NEUROSTIMULATOR (INS) OVER-DISCHARGE WAS SUSPECTED. THE LAST TIME ANY STIMULATION WAS FELT AND THE LAST TIME THERE WAS A SUCCESSFUL CHARGING SESSION WAS TWO TO SIX MONTHS PRIOR. A POWER ON RESET (POR) CONDITION WAS NOTED. FOLLOW UP REPORTED THERE WAS NO ERROR CODE SEEN WITH THE POR AND THE CAUSE OF THE POR WAS UNKNOWN. IT WAS NOTED THE PATIENT WAS EXPERIENCING INTERRUPTED THERAPY DUE TO THE EVENT. A PHYSICIAN MODE RECHARGE (PMR) WAS CONDUCTED BUT WAS UNSUCCESSFUL. IT WAS NOTED THERE COULD BE A POSSIBLE REPLACEMENT. IT WAS ALSO NOTED THE CAUSE OF THE OVER-DISCHARGE WAS 'POSSIBLE DEVICE MALFUNCTION.' ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32538 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