BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 10026678 · Received May 5, 2020

    Report

    Report Number
    3004209178-2020-08124
    Event Type
    Injury
    Date Received
    May 5, 2020
    Date of Event
    September 14, 2009
    Report Date
    May 5, 2020
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    UDI-DI
    00613994287724
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EVENT DATE IS APPROXIMATE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-33, LOT#: V260716, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3093-33, SERIAL/LOT #: (B)(4), UBD: 21-MAY-2013, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT IN 2009 THE PATIENT¿S LEAD WIRES STARTED TO ALMOST STICK OUT OF THEIR SKIN BY THE SPINE BECAUSE THE LEAD BROKE. THE PATIENT¿S HEALTHCARE PROVIDER SAID THAT NOTHING WAS WRONG BECAUSE THE DEVICE STILL WAS WORKING FOR THEM. THE PATIENT STATED THAT THE DEVICE WASN¿T REALLY WORKING BECAUSE THE LEAD WAS BROKEN AND THE ONLY REASON IT WAS STILL WORKING WAS BECAUSE THEIR SKIN WAS HOLDING THE DEVICE TOGETHER. WHEN THE PATIENT WOULD LAY DOWN, THE WIRES WOULD PUSH TOGETHER AND START STIMULATING. THE PATIENT NOTED IT OBVIOUSLY WASN¿T WORKING BECAUSE THEY COULDN¿T LAY DOWN FOREVER, SO THEIR HEALTHCARE PROVIDER REPLACED THE DEVICE IN 2010. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488208 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058 00613994287724

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention