BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1940371 · Received December 20, 2010

    Report

    Report Number
    3004209178-2010-10601
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    September 22, 2010
    Report Date
    December 15, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S NEUROSTIMULATOR HAD MOVED IN HER BODY AND WAS REPLACED. ADDITIONAL INFO HAS BEEN REQUESTED. SEE MANUFACTURER'S REPORT #3004209178-2010-10602 FOR SUBSEQUENT NEUROSTIMULATOR ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention EXTENSION: MODEL 3095, LOT #: NAH040450V| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3889, LOT #: V140956| PROGRAMMER: MODEL 3037, LOT #: NJD073598N