BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2093974 · Received May 16, 2011

    Report

    Report Number
    3004209178-2011-03532
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    January 19, 2011
    Report Date
    May 12, 2011
    Manufacturer
    MEDTRONIC 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS EVENT WAS ORIGINALLY REPORTED IN MFR REPORT # 3004209178-2010-10923. ALL FUTURE FOLLOW UP INFORMATION WILL BE REPORTED IN THIS MFR REPORT. "SUBSEQUENT INFORMATION REPORTED THAT HER NEUROSTIMULATOR HAD IMPEDANCE MEASUREMENTS OF GREATER THAN 4000 OHMS ON ALL BIPOLAR PAIRS. WHEN THE TEST WAS RERUN WITH THE DEFAULT VALUES INCREASED, IMPEDANCES WERE GREATER THAN 4000 OHMS ON ALL ELECTRODES EXCEPT C TO #3 (INCREASED VALUES UP TO 2.0 VOLTS AT 330 PW). THERE WAS NO TRAUMA OR FALLS ASSOCIATED WITH THE HIGH IMPEDANCE ISSUE." PER MANUFACTURER'S DEVICE REGISTRATION THE DEVICE WAS EXPLANTED AND REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3058 H0241497

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention IMPLANTED:| LEAD: MODEL 3093, LOT# V259774| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD086499N