BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2171024 · Received June 30, 2011

    Report

    Report Number
    3004209178-2011-04986
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 6, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON, THERE WAS NEVER THERAPEUTIC EFFECT. PHYSICIAN RECOMMENDED A NEW PROGRAMMER WITH DIFFERENT PROGRAM CAPABILITIES TO IMPROVE HER THERAPY. IT WAS REPORTED THAT THE DEVICE CHANGES POSITIONS FROM WHERE IT WAS SET. THERE WAS ONLY PAIN REPORTED FROM THE DEVICE. THE NEXT APPOINTMENT WITH THE DOCTOR WAS (B)(6) 2011. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 66 YR IMPLANTED:| PROGRAMMER: MODEL 3031A, LOT# NGM024243P| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3093, LOT# J0555569V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 3095, LOT NAH025540V