BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2408666 · Received January 10, 2012

    Report

    Report Number
    3004209178-2012-00194
    Event Type
    Malfunction
    Date Received
    January 10, 2012
    Report Date
    December 29, 2011
    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
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PROGRAMMER MODEL 3037 SERIAL# (B)(4); LEAD MODEL 3093-28 LOT# V011296 IMPLANTED: (B)(6) 2006 EXPLANTED: NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SWELLING OVER THEIR IMPLANTABLE NEUROSTIMULATOR POCKET AND PAIN DEPENDING ON BODY MOVEMENT, FOR THE PAST 4-5 DAYS. THE PATIENT ALSO HAD AN ERROR CODE AND POWER-ON-RESET CONDITION MESSAGE DISPLAYED ON THEIR PROGRAMMER. ADDITIONAL INFORMATION HAD 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