BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2052645 · Received April 7, 2011

    Report

    Report Number
    3004209178-2011-02674
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 21, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN INSTRUCTED THE PATIENT TO TURN THE DEVICE OFF AS HE WAS GOING TO BE OUT OF TOWN. THE PATIENT SUBSEQUENTLY EXPERIENCED BACK PAIN AND WAS HOSPITALIZED. THE OUTCOME IS UNKNOWN. FURTHER INFORMATION IS BEING REQUESTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization EXPLANTED:| LEAD: MODEL 3778, LOT# V571323011| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE156744N| ACCESSORY: MODEL 37752, LOT# NKA146917N| LEAD: MODEL 3778, LOT# V557249009| IMPLANTED:| IMPLANTED: