BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4110430 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17529
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    September 2, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 889-28, LOT# V581953, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED,THE PATIENT FELL. THE PATIENT PASSED OUT AND FELL OF THE TOILET. THE PATIENT ALSO FELL DOWN THE STAIRS AND HIT THEIR HEAD ON THE CONCRETE. IT WAS UNCLEAR IF THE FALLS WERE DUE TO UNSAFE MEDICATION OR THE STIMULATOR. THE PATIENT WAS SCARED THE FALLS CRACKED THE SEAL ON THE STIMULATOR AND DID NOT WANT BATTERY ACID GOING THROUGH THEIR BODY. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592372 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Other