BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3841617 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09942
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V824102, IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3037, (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID NEU_UNKNOWN_LEAD, (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE HEALTH CARE PROVIDER COULD NOT GET THE LEAD WIRE OUT AND HE LEFT IT IN¿ .THE PATIENT REPORTED THAT SHE HAS BOTH LEAD WIRES IN STILL. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318017 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1