BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 8871429 · Received August 7, 2019

    Report

    Report Number
    3004209178-2019-15185
    Event Type
    Injury
    Date Received
    August 7, 2019
    Report Date
    August 8, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# V051852, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2019, 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 CONSUMER VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT PATIENT WAS HAVING A REPLACEMENT FOR NORMAL END OF LIFE BATTERY. PATIENT STATED THEY HAD SEVERAL FALLS PREVIOUSLY. MANUFACTURER REPRESENTATIVE (REP) RAN IMPEDANCES AND ALL WERE SHOWING GREATER THAN 4000. IMPEDANCES WERE RAN AT 2 VOLTS AND 300 PULSE WIDTH. THE HEALTHCARE PROFESSIONAL (HCP) DECIDED TO REPLACE BOTH BATTERY AND THE LEAD. ONCE REPLACED, ALL IMPEDANCES WERE WITHIN NORMAL LIMITS. ISSUE RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662789 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention