BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2624921 · Received June 21, 2012

    Report

    Report Number
    3004209178-2012-04725
    Event Type
    Injury
    Date Received
    June 21, 2012
    Report Date
    May 25, 2012
    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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V073596, IMPLANTED: 2007-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-28 LOT# V073596, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE CAUSE OF THE IMPEDANCE ISSUE WAS THE BATTERY NEEDED TO BE REPLACED. AFTER THE BATTERY REPLACEMENT, THE RESULT WAS NOTED AS "GOOD," AND REPROGRAMMING WAS PERFORMED ABOUT THREE WEEKS LATER ON (B)(6) 2012. THE PATIENT DID NOT REQUIRE HOSPITALIZATION, AND THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT THE ORIGINAL IMPLANTABLE NEUROSTIMULATOR (INS) WAS KEPT BY THE HOSPITAL AND THE PATIENT WAS DOING FINE AFTER THE REPLACEMENT. THE IMPEDANCE ISSUE WAS AN UNKNOWN CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF STIMULATION SENSATION. THERE WAS A REPORT OF A FALL PRIOR TO LOSING STIMULATION, BUT THE TIMELINE AS IT RELATES TO LOSS OF STIMULATION WAS UNCLEAR. IT WAS UNCLEAR IF THERE WERE IMPEDANCE ISSUES. THE DEVICE WAS REPLACED ON (B)(6) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention