BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 9221945 · Received October 22, 2019

    Report

    Report Number
    3007566237-2019-02185
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Report Date
    October 22, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 388928, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 388928, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL VIA THE MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT EXPERIENCED ZAPPING SENSATION FROM THEIR DEVICE SYSTEM. THE PATIENT¿S SYMPTOMS HAVE ALSO RETURNED. THIS EVENT WAS POSSIBLY RELATED TO A LEAD FRACTURE OR DISLODGED DUE TO HORSE RIDING. DIAGNOSTICS/TROUBLESHOOTING WAS PERFORMED, IMPEDANCE TESTS WITH ALL READING ABOVE 4,000 OHMS. THE NURSE TRIED TO REPROGRAMMING BUT WAS NOT SUCCESSFUL. THE PATIENT WAS BOOKED TO BE SEEN BY THEIR HEALTHCARE PROFESSIONAL ON (B)(6) 2019 FOR FURTHER INVESTIGATION. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THIS REPORT. NO SURGICAL INTERVENTION OCCURRED. THE PATIENT WAS ALIVE WITH NO INJURY. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010999 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058

    Patients

    Seq Age Sex Outcome Treatment
    1