BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3842708 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09944
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    October 29, 2013
    Report Date
    May 29, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3093-33, LOT# V617801, IMPLANTED: 2011 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO SIGNIFICANT ANOMALIES. IT WAS NOTED THAT THE INS WAS FUNCTIONALLY OKAY WITH INSIGNIFICANT ANOMALIES. ANALYSIS OF THE LEAD FOUND THAT THE LEAD BODY CONDUCTOR WAS BROKEN AT OR NEAR TINES.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT¿S DEVICE WAS CAUSING HER PAIN, DESCRIBED AS A STABBING FEELING. ADDITIONAL INFORMATION STATED, THE PATIENT HAD STABBING PAIN AT THE DEVICE LOCATION ADDITIONAL INFORMATION REPORTED THEY TEMPORARILY DISCONTINUED STIMULATION AND THEN THE LEAD AND STIMULATOR WERE EXPLANTED. THE EVENT WAS NOTED AS RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS DISCOMFORT IF THE DEVICE WAS PUSHED AGAINST SOMETHING. THE REMOVAL OF THE DEVICE WAS NOTED AS DUE TO DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320787 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention