BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 6089664 · Received November 9, 2016

    Report

    Report Number
    3004209178-2016-23529
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    November 1, 2014
    Report Date
    November 9, 2016
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3889-28, LOT # V850492, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2016, PRODUCT TYPE LEAD.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER (CON) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR FECAL INCONTINENCE. IT WAS REPORTED THAT THE PATIENT HAD A BAD FALL THREE DAYS BEFORE (B)(6) 2014. THE FALL RESULTED IN A FRACTURED LEAD WIRE. THE IMPLANTABLE NEUROSTIMULATOR (INS) AND THE LEAD WERE REVISED ON (B)(6) 2016 AND THE PATIENT RECOVERED COMPLETELY. THERE WERE NO PATIENT SYMPTOMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739749 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention