BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3241259 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12112
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 28, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-33, LOT# V309454, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-33, LOT# V309454, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FALL INTO A LAWN MOWER AND SUBSEQUENTLY HAD HER DEVICE REPLACED. THE DATE OF THE FALL WAS UNKNOWN. THE PATIENT HAD BEEN SEEN BY A HEALTH CARE PROFESSION ABOUT A MONTH PRIOR TO THE REPORT, AND ALL IMPEDANCES WERE GREATER THAN 4000 OHMS. THE PATIENT¿S SYMPTOMS HAD RETURNED AND THE PATIENT HAD NO STIMULATION SENSATION. AN X-RAY SHOWED THAT THE LEAD WAS NOT IN THE CORRECT POSITION. THE LEAD WAS REMOVED WITHOUT ANY ISSUES. A NEW SYSTEM WAS PLACED ON (B)(6) 2013. IT WAS FURTHER CLARIFIED THAT BOTH THE LEAD AND IMPLANTABLE NEUROSTIMULATOR (INS) WERE DAMAGED. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341370 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention