BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7404126 · Received April 6, 2018

    Report

    Report Number
    3004209178-2018-06676
    Event Type
    Injury
    Date Received
    April 6, 2018
    Date of Event
    April 4, 2018
    Report Date
    May 7, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3889-28, SERIAL/LOT #: (B)(4), UBD: (B)(6) 2015, PRODUCT ID 3889-28 LOT# V881399 IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) VIA A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/ PELVIC FLOOR IT WAS REPORTED THAT PATIENT¿S DEVICE AND LEAD WERE REMOVED DUE TO LACK OF EFFICACY. NO COMPLICATIONS REPORTED. NO FURTHER SYMPTOMS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE CAUSE OF LACK OF EFFICACY WAS NOT DETERMINED. THE PROVIDED INFORMATION HAS BEEN CONFIRMED WITH THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244899 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention