BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3606881 · Received February 4, 2014

    Report

    Report Number
    3004209178-2014-01553
    Event Type
    Injury
    Date Received
    February 4, 2014
    Report Date
    January 16, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V813487 IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, 4 EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN IMPEDANCE ISSUE. THE ENTIRE SYSTEM WAS REPLACED. INFORMATION RECEIVED FIVE DAYS LATER INDICATED THE MANUFACTURER REPRESENTATIVE CHECKED IMPEDANCES ON THE NEW DEVICE. THE NEW DEVICE WAS FUNCTIONING PROPERLY AND WAS TURNED ON. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73397 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention