BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2129978 · Received June 9, 2011

    Report

    Report Number
    3004209178-2011-04230
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    August 28, 2010
    Report Date
    April 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SIGNIFICANT ANOMALIES. IPG IS FUNCTIONALLY OK. POR OCCURRED PRIOR TO ANALYSIS. INS OUTPUT WAS TESTED AT THE DISTAL END OF A KNOWN GOOD LEAD. GOOD, STABLE OUTPUT WAS OBSERVED ON EACH ELECTRODE PAIR ON AN OSCILLOSCOPE, ACROSS A 510 OHM LOAD, CONNECTED TO THE DISTAL END OF THE LEAD. #3889 - V072260 - RELIABILITY NON-CONFORMANCE. BROKEN CONDUCTOR WIRE IN CIRCUIT #2, NEAR THE TINES AREA. CONTINUITY ACCEPTABLE TO CUT ENDS OF CIRCUITS #0, 1 AND 3, NO SHORTS (DRY).

    Description of Event or Problem · 1

    RECEIVED INFO THE INS "JUST QUIT WORKING". NO HIGH IMPEDANCES WERE FOUND AND THE LEAD APPEARED INTACT. THE INS AND LEAD WERE REPLACED AND RETURNED TO THE MFR FOR ANALYSIS. ANALYSIS OF THE LEAD REVEALED A BROKEN CONDUCTOR WIRE. THERE WAS NO PT INJURY AND THE PT RECOVERED WITHOUT SEQUELAE.

    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 37 YR Required Intervention EXPLANTED:| LEAD: MODEL 3889, LOT# V072260| IMPLANTED: