BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2770888 · Received October 3, 2012

    Report

    Report Number
    3004209178-2012-08849
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 7, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-33, LOT# V711814, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS TELEMETRY ISSUES AND PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS UNABLE TO COMMUNICATE WITH IMPLANTABLE NEUROSTIMULATOR (INS); IT KEPT SAYING THERE WAS INTERFERENCE. PATIENT WAS NOT GETTING THERAPY RELIEF FOR 2-3 MONTHS AND HAD BEEN EXPERIENCING SYMPTOMS RETURN. PATIENT HAD A FALL 3 WEEKS PRIOR TO THE DATE OF THIS REPORT. IT WAS NOTED THAT THE PHYSICIAN HAD SEVERAL BATTERIES THAT HAVE ONLY LASTED 2 OR 2.5 YEARS. FOLLOW-UP INFORMATION REPORTED THAT DIAGNOSTICS WERE ATTEMPTED; HOWEVER BATTERY APPEARED TO BE DEAD. THE CAUSE OF EVENT WAS UNKNOWN. THE PATIENT WAS SCHEDULED TO REPLACE THE BATTERY AND THE LEAD ON (B)(6) 2012. IT WAS SUSPECTED THAT LEAD WAS DAMAGED. THERE WERE NO CHANGES IN PATIENT'S STATUS. IT WAS LATER REPORTED THAT THE LEAD WAS TESTED WITH VERY MINIMAL MOTOR RESPONSE ON ONLY ONE ELECTRODE. THE DOCTOR DECIDED TO REPLACE THE LEAD, AND GREAT RESPONSE WAS OBTAINED.

    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