BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5205421 · Received November 5, 2015

    Report

    Report Number
    3004209178-2015-22307
    Event Type
    Injury
    Date Received
    November 5, 2015
    Date of Event
    October 16, 2015
    Report Date
    November 8, 2023
    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
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.¿

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # V772374, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2015, PRODUCT TYPE LEAD; PRODUCT ID 3889-28, LOT # V772374, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2015, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE (B)(4) REVEALED THE NEUROSTIMULATOR (INS) NO SIGNIFICANT ANOMALY, NORMAL END OF LIFE AND NO TELEMETRY NO OUTPUT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED LOSS OF EFFICACY AND THE BATTERY WAS UNREADABLE. IT WAS UNKNOWN WHAT LED TO THE EVENT IT COULD HAVE BEEN BATTERY OR LEAD FRACTURE OR BOTH. THE DEVICE WAS INTERROGATED. THERE WAS NONE INTERVENTION TAKEN TO RESOLVE THE ISSUE BUT WAS ALSO NOTED THAT THE DEVICE WAS EXPLANTED COMPLETELY. IT WAS NOTED THAT THE ISSUE WAS RESOLVE AT THE TIME OF THIS REPORT. THE INDICATIONS FOR USE FOR THIS PATIENT WERE URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734638 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Female Required Intervention "SEE H10...."