BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3339220 · Received September 10, 2013

    Report

    Report Number
    3004209178-2013-15960
    Event Type
    Malfunction
    Date Received
    September 10, 2013
    Date of Event
    August 14, 2013
    Report Date
    August 14, 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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V001560, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELT AN INCREASE IN STIMULATION WHEN BEING MASSAGED. THE PATIENT WAS SEEING A CHIROPRACTOR BECAUSE THEY WERE HAVING LUMBAR BACK ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453827 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR