BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 6313012 · Received February 8, 2017

    Report

    Report Number
    3004209178-2017-02874
    Event Type
    Injury
    Date Received
    February 8, 2017
    Date of Event
    October 1, 2015
    Report Date
    February 8, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-33, LOT# V911221, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. (B)(4). 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.

    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 FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR. THE PATIENT REPORTED THAT SHE FELL DOWN THE STAIRS (AROUND (B)(6) 2015) AFTER HAVING PAIN FROM A HYSTERECTOMY (PAIN AND HYSTERECTOMY UNRELATED TO IMPLANT). THE PATIENT REPORTED THAT SHE BEGAN HAVING CONSTIPATION ISSUES AND IT WAS DETERMINED THE WIRES HAD BROKEN SO SHE HAD THE SYSTEM REPLACED. THE PATIENT REPORTED THAT A MANUFACTURER¿S REPRESENTATIVE WAS AWARE AT THE TIME AND HAD PROGRAMMER HER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94093 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention