BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1180994 · Received September 29, 2008

    Report

    Report Number
    3004209178-2008-06184
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NOT FELT ANY STIMULATION SENSATION SINCE HE "COUGHED REALLY HARD". THE PATIENT WAS DIRECTED TO HIS HCP. NO OTHER SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED 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. 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR LEAD: MODEL 3777| EXPLANTED:| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743| IMPLANTED: