BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1913572 · Received November 12, 2010

    Report

    Report Number
    9614453-2010-09450
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 8, 2010
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED INTERMITTENT STIMULATION ALTHOUGH THE DEVICE APPEARED TO BE SWITCHED OFF. HOWEVER, AFTER REACTIVATION WITH THE PROGRAMMER, THE DEVICE HAD ALSO CHANGED GROUPS. THE PT EXPERIENCED DISCOMFORT WITH PERIODS OF NO STIMULATION. 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 PRIME ADVANCED LGW MEDTRONIC EUROPE SARL 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1