BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1201523 · Received October 17, 2008

    Report

    Report Number
    3004209178-2008-06630
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    April 4, 2008
    Report Date
    September 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERAITONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL IMPLANTABLE NEUROSTIMULATOR EVALUATION METHOD. FINAL DEVICE ANALYSIS REVEALED 'NO ANOMALY FOUND, NORMAL DEVICE FUNCTION'. THE LEADS WERE OK, BUT CUT THROUGH (SUSPECTED EXPLANT DAMAGE). FINAL DEVICE ANALYSIS REVEALED 'NO ANOMALY FOUND.' SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED PAIN AT THE IMPLANTABLE NEUROSTIMULATOR POCKET. THE SITE WAS NOT INFECTED AS CONFIRMED WITH NEGATIVE CULTURES. THE DEVICE SYSTEM WAS EXPLANTED. THE PATIENT OUTCOME WAS REPORTED AS 'NO INJURY, RECOVERED WITHOUT SEQUELA'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERAITONS CO. 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention LEAD MODEL 3778 LOT# V084152007| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD MODEL 3778 LOT# V001577| IMPLANTED:| EXPLANTED:| RECHARGER MODEL 37752 LOT# NKA035631N| EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER MODEL 37742 LOT# NJD061509N