BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2231133 · Received August 26, 2011

    Report

    Report Number
    3004209178-2011-06922
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    January 1, 2008
    Report Date
    August 22, 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
    SD, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S IMPLANTABLE NEUROSTIMULATOR WAS TURNED OFF ONE YEAR AFTER IMPLANTATION AS GOOD SYMPTOM CONTROL WAS NOT RECEIVED. IT WAS REPORTED ON (B)(6) 2011, THAT IT WAS NOT POSSIBLE TO COMMUNICATE WITH THE DEVICE USING THE CLINICIAN PROGRAMMER. IT WAS LATER REPORTED THAT THE CAUSE OF THE EVENT WAS A DEPLETED BATTERY. IT WAS ALSO NOTED THAT THE LEAD WAS PLACED IN THE WRONG LOCATION. THE LEAD WAS PLACED IN THE S2 FORAMEN. THE NEUROSTIMULATOR AND LEAD WERE REMOVED AND REPLACED. THE PT DID NOT REQUIRE HOSPITALIZATION AND THERE WAS NO INJURY TO THE PT. THE EVENT WAS NOTED TO BE "NON-SERIOUS."

    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 50 YR Required Intervention IMPLANTED:| EXTENSION: MODEL 3095, LOT# NAH012108V| IMPLANTED:| LEAD: MODEL 3889, LOT# J0436936V| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3031A, LOT# NGM011868P