BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 6503228 · Received April 19, 2017

    Report

    Report Number
    3004209178-2017-08565
    Event Type
    Injury
    Date Received
    April 19, 2017
    Report Date
    May 5, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3889-28, LOT# V223177, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD.

    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 CONSUMER (CON) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT HAD A LEAD ISSUE. THEY WEREN'T SURE WHY THE DEVICE WAS REPLACED, BUT STATED THAT THE WIRES WERE MESSED UP ON THE DEVICE SO THEY HAD A NEW SYSTEM PUT IN. THE REVISION OCCURRED ON (B)(6) 2016. IT WAS NOTED THAT THE PATIENT RECOVERED COMPLETELY. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTED THE STATEMENT OF THE WIRES BEING MESSED UP MEANT THE LEADS HAD MIGRATED. A FOLLOW-UP APPOINTMENT WAS SCHEDULED WITH THE HEALTHCARE PROVIDER (HCP) FOR THE FOLLOWING MONTH. NO FURTHER COMPLICATIONS WERE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285877 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention