BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1061960 · Received June 16, 2008

    Report

    Report Number
    3004209178-2008-03260
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 19, 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 THE PT FELT A SHOCKING SENSATION IN THE DEVICE POCKET WHEN THE VOLTAGE WAS INCREASED TO 7.5 VOLTS. ADDITIONAL INFO REPORTED THE INS HAD BEEN TURNING OFF DURING ADJUSTMENTS TO THE VOLTAGE. NO MESSAGE WAS RECORDED ON THE PROGRAMMER. NO IMPEDANCE WAS NOTED. THE PT HAD BEEN RECHARGING MORE OFTEN THAN WAS CALCULATED. THE HCP HAD SCHEDULED SURGERY TO RESOLVE THE SHOCKING ISSUES AND MAY REPLACE THE INS AS NECESSARY. NO OUTCOME WAS REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention LEAD MODEL 3778| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION MODEL 37081| EXTENSION MODEL 37081| EXPLANTED:| PROGRAMMER MODEL 37742| ACCESSORY MODEL 37752| LEAD MODEL 3378| EXPLANTED: