BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2041382 · Received March 24, 2011

    Report

    Report Number
    3004209178-2011-02267
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 9, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED AN INCREASE IN STIMULATION SINCE IMPLANT WHEN: SHE TALKS ON HER CELL PHONE; USES LAPTOP; NEAR MICROWAVE; BY CLINIC COMPUTER. IT WAS NOTED THE LEADS WERE PLACED IN CERVICAL AREA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB037786V| IMPLANTED:| LEAD: MODEL 3778, LOT# V553160035| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| STIM: ACCESSORY MODEL 3550-39, LOT# N275368| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE160225N| EXPLANTED:| LEAD: MODEL 3778, LOT# V564239005| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB081472V