BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2060940 · Received March 14, 2011

    Report

    Report Number
    3004209178-2011-01896
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 25, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A POWER-ON RESET (POR) CONDITION. THE PATIENT TRIED CLEARING THE POR BUT WAS RECEIVING AN EXCLAMATION POINT (!) MESSAGE AND A "CALL YOUR DOCTOR" ICON. THE PATIENT TYPICALLY RECHARGED EVERY 1.5 WEEKS AND WHEN HE WENT TO RECHARGE HE RECEIVED THE POR. THE PATIENT HAD A CT SCAN ABOUT A MONTH PRIOR TO THE POR MESSAGE. BEFORE THE CT SCAN WAS PERFORMED THE STIMULATOR WAS TURNED OFF. AFTER THE CT SCAN THERE WERE NO CHANGES IN STIMULATION OR RECHARGING UNTIL THE POR CONDITION ABOUT A MONTH LATER. WHEN THE STIMULATOR WAS INTERROGATED WITH A PHYSICIAN PROGRAMMER, THERE WAS A DISCHARGED BATTERY MESSAGE. THE POR WAS CLEARED AND THE STIMULATOR WAS RECHARGING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, 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 ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR ACCESSORY: MODEL 37752, LOT# NKA124915N| LEAD: MODEL 3487A, LOT# J0545140V| PROGRAMMER: MODEL 37743, LOT# NKE122692N| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB016475N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT# J0511558V| IMPLANTED:| IMPLANTED:| EXPLANTED: