BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1162109 · Received September 16, 2008

    Report

    Report Number
    3004209178-2008-05844
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 21, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED NO STIMULATION IN HIS BACK. THE PT ALSO INDICATED THAT HIS BACK PAIN WAS WORSE THAN BEFORE THE IMPLANT. THE PT WAS REPROGRAMMED MULTIPLE TIMES WITHOUT SUCCESS. THE DECISION WAS MADE TO DO A REVISION. A REVISION WAS PERFORMED. THE PT WAS PROGRAMMED SEVERAL TIMES BEFORE REACHING OPTIMAL THERAPY.

    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| EXPLANTED| LEAD MODEL 3777 LOT# V065994030 IMPLANTED| LEAD MODEL 3777 LOT# V065994026 IMPLANTED| PROGRAMMER MODEL 37742 LOT# NJD059831N