BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1280551 · Received January 5, 2009

    Report

    Report Number
    3004209178-2009-00056
    Event Type
    Injury
    Date Received
    January 5, 2009
    Date of Event
    December 1, 2008
    Report Date
    December 9, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED NO STIMULATION SENSATION. IMPEDANCES READINGS WERE >40,000 OHMS. THE BATTERY LEVEL WAS CHECKED AND FOUND TO BE OK. X-RAYS NOTED NO DISCONNECTIONS. REVISION SURGERY HAD BEEN SCHEDULED FOR EARLY 2009. 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 PRIME ADVANCED LGW MEDTRONIC PUERTO RICO OPERATIONS CO 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention EXPLANTED:| IMPLANTED:| UNK CONVERSION TYPE: MODEL LEADN