BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2211055 · Received August 5, 2011

    Report

    Report Number
    3007566237-2011-06116
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO TELEMETRY WITH THE INS. ENVIRONMENTAL OR MEDICAL PROCEDURE INTERFERENCE HAD NOT BEEN RULED OUT. WHEN THEY MOVED TO A DIFFERENT AREA AWAY FROM THE NEARBY COMPUTER, THEY WERE ABLE TO ESTABLISH COMMUNICATION WITH THE INS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC NEUROMODULATION 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROGRAMMER: MODEL 8840, LOT# UNKNOWN| IMPLANTED:| EXPLANTED: