BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1970124 · Received January 14, 2011

    Report

    Report Number
    3004209178-2011-00396
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    October 12, 2010
    Report Date
    January 10, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S DEVICE WAS EXPLANTED DUE TO LOSS OF THERAPEUTIC EFFECT. THE PT WAS EXPERIENCING URGENCY AND FREQUENCY. THE PTS PHYSICIAN FELT AS IF THE LEADS WERE NOT FUNCTIONING ADEQUATELY. IN ADDITION, THE NEUROSTIMULATOR HAD NO POWER. THE PT RETURNED TO THE PHYSICIAN'S OFFICE ON (B)(6) 2010 FOR REPROGRAMMING AND SEEMED TO BE DOING FINE.

    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 46 YR Required Intervention EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 3095, LOT# NAH014225V| LEAD: MODEL 3889, LOT# J0424963V| IMPLANTED:| EXPLANTED: