BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7311324 · Received March 2, 2018

    Report

    Report Number
    3007566237-2018-00633
    Event Type
    Injury
    Date Received
    March 2, 2018
    Date of Event
    February 7, 2018
    Report Date
    March 2, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. INFORMATION INDICATES THERE WAS HIGH IMPEDANCE WITH BOTH OF THE SYSTEMS THE LEAD WAS CONNECTED TO. SEE MANUFACTURER REPORT #30042091 78-2018-04382 FOR THE REPORT ON THE OTHER SYSTEM. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED BY THE REP THAT THE HEALTH CARE PHYSICIAN (HCP) ENDED UP REPLACING THE LEAD AND THE INS ENTIRELY DUE TO IMPEDANCE OVER 4K OHMS. THE REP NOTED THEY SAW THE BLUE TIP, THE HCP MADE SURE THE LEAD WAS SECURE AND THE REP CHECKED FOR BODY RESPONSE. INITIALLY THE HCP REPLACED THE INS BUT WHEN IMPEDANCES WERE STILL GREATER THAN 4K OHMS, THE LEAD WAS THEN REPLACED. THERE WERE NO SYMPTOMS AND NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152400 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention