BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2251184 · Received September 8, 2011

    Report

    Report Number
    3004209178-2011-07553
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    August 29, 2011
    Report Date
    August 29, 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
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD ANOTHER POR AFTER USING THE ANTENNA LOCATE FEATURE. THE PATIENT WAS REDIRECTED TO HER PHYSICIAN SO IT COULD BE CLEARED WITH A CLINICIAN PROGRAMMER. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION COULD NOT BE ADJUSTED AND A 'CALL YOUR DOCTOR' ICON WAS DISPLAYED. THERE WAS A POWER ON RESET (POR) CONDITION. THE POR CONDITION WAS SUBSEQUENTLY CLEARED AND THE PATIENT WAS ABLE TO TURN ON STIMULATION. IT WAS REPORTED THAT STIMULATION WAS RUNNING AT A COMFORTABLE LEVEL.

    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 48 YR EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL 3550-29, LOT# N129239| EXPLANTED:| LEAD: MODEL 3778, LOT# V094558011| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE103285N| ACCESSORY: MODEL 37752, LOT# NKA111352N| EXPLANTED: