BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2517696 · Received April 5, 2012

    Report

    Report Number
    3004209178-2012-02120
    Event Type
    Injury
    Date Received
    April 5, 2012
    Report Date
    June 14, 2018
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3093-28, LOT# V813549, IMPLANTED: 2011 (B)(6), EXPLANTED: 2012 (B)(6), PROGRAMMER MODEL 3037, SERIAL# (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    CONTINUATION OF D11: PRODUCT ID (B)(4) LOT# SERIAL# (B)(4) IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID (B)(4) LOT# (B)(4) SERIAL# IMPLANTED: (B)(4) 2011 EXPLANTED: (B)(4) 2012 PRODUCT TYPE LEAD PRODUCT ID (B)(4) LOT# (B)(4) SERIAL# IMPLANTED: (B)(4) 2011 EXPLANTED: (B)(4) 2012 PRODUCT TYPE LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NO STIMULATION SENSATION AND NEVER HAD THERAPEUTIC EFFECT FROM THE DEVICE. IT WAS NOTED THE PATIENT ALSO HAD CONSTIPATION. THE PATIENT HAD HAD A SUCCESSFUL TRIAL EXPERIENCE THOUGH. X-RAYS WERE TAKEN AND THE RESULTS SHOWED EVERYTHING WAS NORMAL. HOWEVER, LATER IT WAS REPORTED THE LEAD HAD MOVED AND NEEDED TO BE REVISED. THE LEAD WAS EXPLANTED AND REPLACED, AND AFTERWARDS THE PATIENT SEEMED TO BE DOING WELL. THE PATIENT FELT STIMULATION IN THE APPROPRIATE PLACES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT AND IT WAS REPORTED THAT THEY NOTICED IMMEDIATELY AFTER THE DEVICE WAS IMPLANTED THAT THEY WERE CONSTIPATED. AFTER REPOSITIONING LEADS, CONSTIPATION IMPROVED. IT WAS NOTED THAT PATIENT WAS ALSO EXPERIENCING STIMULATION ON THEIR BACKSIDE WITH THEIR FIRST DEVICE ON PROGRAM 4. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention