BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2152309 · Received June 23, 2011

    Report

    Report Number
    3004209178-2011-04702
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 26, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL (HCP) MEASURED IMPEDANCES > 4,000 OHMS ON SOME OF THE BIPOLAR PAIRS. AT THE PATIENT'S SETTINGS THE IMPEDANCES WERE C-0=1423, C-1=1147, C-2=1111, C-3=1111 0-1=>4000, 0-2=>4000, 0-3=>4000, 1-2=>4000, 1-3=>4000, AND 2-3=2085. THE SYSTEM SETTINGS WERE CHANGED TO 1.7V AND PW = 300. THE IMPEDANCES WERE THEN C-0= 1360, C-1=1360, C-2=983, C-3=1360, 0-1=2730, 0-2=2730, 0-3=2730, 1-2=1819, 1-3=2730, AND 2-3=2648. THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION THAT WAS RELATED TO POSITION. THE PATIENT DID NOT FEEL ANY SHOCKING WHEN THE SYSTEM WAS PALPATED. SHE FELT SHOCKING IN HER VAGINAL AREA WHEN THE IMPEDANCES WERE TESTED AT 1.7V. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR PROGRAMMER: MODEL 3037, LOT# NJD116370N| LEAD: MODEL 3889, LOT# V534762| EXPLANTED:| IMPLANTED: