BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1231162 · Received November 12, 2008

    Report

    Report Number
    3004209178-2008-07387
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 13, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED PERIODIC SHARP DISCOMFORT IN THE POCKET. IMPEDANCE READINGS REVEALED ELECTRODES 0, 1, AND 2 ALL GREATER THAN 10,000 OHMS AT 1.5V. NO PT TREATMENT OR OUTCOME WAS REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 41 YR EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| RECHARGER: MODEL 37752| EXTENSION: MODEL 37083| PROGRAMMER: MODEL 37743| LEAD: MODEL 3998| EXTENSION: MODEL 37083