BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2220002 · Received August 9, 2011

    Report

    Report Number
    3004209178-2011-06190
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Report Date
    July 14, 2011
    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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT QUESTIONED THE "TOTAL EFFECTIVENESS" OF THE IMPLANTABLE NEUROSTIMULATOR. IT WAS SUGGESTED THAT THE LEAD HAD "COME LOOSE." ADD'L INFO WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    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 EXTENSION: MODEL 3095, LOT# NAH022285V| LEAD: MODEL 3093, LOT# J0527320V| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3031A, LOT# NGM020482P