BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3002536 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03661
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 20, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28 LOT# V086630, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3095-10 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3037 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE, SERIAL #(B)(4), FOUND IT FUNCTIONALLY OKAY AND NO SIGNIFICANT ANOMALIES. ANALYSIS OF THE EXTENSION, SERIAL #(B)(4), FOUND NO ANOMALY. ANALYSIS OF THE LEAD, LOT #V8037353, FOUND ALL OF THE CONDUCTOR WIRES BROKEN 10.6 CENTIMETERS FROM THE MARKER BAND.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD EXPERIENCED A LOSS OF EFFICACY DUE TO THE REPORTED EVENT. IT WAS NOTED THAT THE IMPEDANCES OVER 4,000 OHMS WERE SEEN ON ALL ELECTRODE PAIRS EXCEPT 1/2. IT WAS CLARIFIED THAT THE LEAD FRACTURED WHEN REMOVAL WAS ATTEMPTED, AND A NEW LEAD WAS PLACED ON THE SAME SIDE. IT WAS UNCLEAR IF THE FRAGMENTS WERE REMOVED. IT WAS NOTED THAT THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED IMPEDANCE READINGS >4000 OHMS ON SOME OF THE BIPOLAR PAIRS. IT WAS NOTED THAT THERE ARE OPEN CIRCUITS ON THE LEAD THAT WILL BE ADDRESSED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SYSTEM WAS EXPLANTED AND REPLACED. THE DEVICE WAS NOT WORKING AND THERE WAS LEAD FRACTURED AT REMOVAL. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105068 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention