BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2491661 · Received March 14, 2012

    Report

    Report Number
    3004209178-2012-01575
    Event Type
    Malfunction
    Date Received
    March 14, 2012
    Report Date
    February 20, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3093-28, LOT# V863548, IMPLANTED (B)(6) 2012, EXPLANTED UNK; PROGRAMMER: MODEL 3031A, SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING IMPLANT THE PATIENT BROKE OUT ON HER RIGHT ARM, FACE, CHEST, BACK, AND HALFWAY UP HER HEAD. THE CONDITION HAD SLOWLY CLEARED UP, AND THE PATIENT BELIEVED IT WAS DUE TO THE HOSPITAL GOWN. THE PATIENT ALSO EXPERIENCED ACUTE PAIN AND A SHOCKING OR JOLTING SENSATION IN HER LEFT HIP. THE SHOCKING OCCURRED ON (B)(6) 2012 AND THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. THE PAIN OCCURRED WHEN THE IMPLANTABLE NEUROSTIMULATOR TURNED ON BY ITSELF. THE SHOCKING WENT AWAY WITHIN A FEW SECONDS AND THEN IT WAS FINE. 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 II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1