BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4157434 · Received October 9, 2014

    Report

    Report Number
    3004209178-2014-18639
    Event Type
    Injury
    Date Received
    October 9, 2014
    Report Date
    September 17, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V933654, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE LEAD WAS PLANNED TO BE EXPLANTED TWO DAYS AFTER REPORTED EVENT DATE. THE LOSS OF THERAPEUTIC EFFECT WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF REPORT. IF ADDITIONAL INFORMATION RECEIVED, SUPPLEMENTAL WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED A MONTH LATER REVEAL THE LEAD FAILED AFTER BEING IMPLANTED FOR A YEAR OR SO. WHEN THE HEALTHCARE PROVIDER WENT IN TO REPLACE IT, THE LEAD WAS FUSED IN THE HEADER BLOCK LIKE CORRODED IN PLACE. IT WAS REPORTED THREE DAYS LATER THAT IT JUST STOPPED PROVIDING BENEFIT AND THE LEAD WAS SWITCHED OUT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED BY THE HEALTHCARE PROVIDER THAT THEY DID NOT KNOW WHY THE LEAD FAILED. IT WAS ALSO NOTED THAT, REGARDING THE HEALTHCARE PROVIDER BEING UNABLE TO REMOVE THE LEAD FROM THE INS AND THE HEALTHCARE PROVIDER'S CONCLUSION WAS IT MUST BE STUCK LIKE IT MAY HAVE BEEN CORRODED, THIS ISSUE PERTAINED TO A DIFFERENT PATIENT. (SEE MANUFACTURER'S REPORT # 004209178-2014-19439 FOR THIS OTHER EVENT INVOLVING A DIFFERENT PATIENT.) THIS PATIENT WAS DOING WELL WITH REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634119 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention