BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5099403 · Received September 24, 2015

    Report

    Report Number
    3004209178-2015-18577
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    May 7, 2015
    Report Date
    August 31, 2015
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V840309, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3889-28, LOT# V840309, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT LEAD DAMAGE WAS DISCOVERED DURING IMPLANTABLE NEUROSTIMULATOR REPLACEMENT FOR NORMAL END OF LIFE. THE LEAD WIRE WAS ALSO REPLACED DURING THE PROCEDURE TO REPLACE THE INS. THERE WERE NO SYMPTOMS REPORTED. SHE WAS INDICATED FOR GASTROINTESTINAL/ PELVIC FLOOR. NO FURTHER INFORMATION WAS PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632038 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Required Intervention