BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 8160799 · Received December 13, 2018

    Report

    Report Number
    3004209178-2018-27588
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    November 25, 2013
    Report Date
    January 23, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-33, LOT# V941222, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3093-33, SERIAL/LOT #: V941222, UBD: 09-FEB-2016. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-33, LOT# V941222, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) VIA A HEALTHCARE PROVIDER (HCP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FECAL INCONTINENCE AND GASTROINTESTINAL/PELVIC FLOOR. HCP REPLACED THE LEAD BECAUSE THE PATIENT COMPLAINED OF NOT GETTING SYMPTOM RELIEF. NO DEVICE ISSUE WAS REPORTED AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE PATIENT NEVER FELT HAPPY WITH THE BOWEL SYMPTOM RELIEF FROM THEIR DEVICE. NO DEFINITIVE CAUSE WAS DETERMINED, BUT THE PATIENT FEEDBACK WAS PRECIPITOUS TO THE FULL REPLACEMENT OF THE SYSTEM. IT WAS NOTED THAT THE EXPLANT OCCURRED IN 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001448 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention