BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1230008 · Received November 12, 2008

    Report

    Report Number
    3004209178-2008-07375
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    March 11, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMMEDIATELY POST-OP THE PATIENT HAD NO STIMULATION SENSATION ON ONE SIDE. THE PHYSICIAN WAITED 24 HOURS, THEN THE PATIENT WENT BACK TO SURGERY FOR REVISION USING THE SAME LEAD. NO PATIENT OUTCOME WAS REPORTED. ADDITIONAL INFORMATION 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 40 YR Required Intervention IMPLANTED:| RECHARGER: MODEL 37752| PROGRAMMER: MODEL 37743| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083| LEAD: MODEL 3998| EXPLANTED:| EXTENSION: MODEL 37083| IMPLANTED:| EXPLANTED: