BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1060651 · Received June 13, 2008

    Report

    Report Number
    3004209178-2008-03216
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    April 1, 2008
    Report Date
    May 15, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD DIFFICULTIES WITH RECHARGING. IT WAS ALSO REPORTED THE STIMULATION WAS IN THE WRONG LOCATION AND THE PT FELT A BURNING SENSATION. THIS OCCURRED FOLLOWING A RECENT UNSPECIFIED TRAUMA. NO OTHER SYMPTOMS OR OUTCOME WERE 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 Required Intervention EXPLANTED| LEAD MODEL 3998 LOT# UNK IMPLANTED| EXPLANTED| EXTENSION MODEL 37083 LOT# NKC008182N IMPLANTED| EXPLANTED| EXTENSION MODEL 37083 LOT# NKC011111N IMPLANTED