BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1101831 · Received August 7, 2008

    Report

    Report Number
    3004209178-2008-04749
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS ABLE TO PRESS ON THE INS AND MAKE THE STIMULATION STOP. WHEN THE INS WAS RELEASED, THE STIMULATION RETURNED. IMPEDANCE READINGS WERE >10000 OHMS. THE PT HAD A LEAD REVISION. THE LEAD HAD MIGRATED INTO THE POCKET. THE INS CONTACTS WERE WIPED AND DRIED AFTER THE LEAD WAS REVISED. ALL IMPEDANCE READING WERE WITHIN NORMAL RANGE FOLLOWING THE REVISION. NO FURTHER OUTCOME WAS REPORTED. 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 Required Intervention LEAD MODEL 3888 LOT# V122051| EXPLANTED:| LEAD MODEL 3888 LOT# V089529| EXPLANTED:| IMPLANTED:| PROGRAMMER MODEL 37743 LOT# NKE104544N| ACCESSORY MODEL 37752 LOT# NKA037601N| IMPLANTED: