BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3770552 · Received April 24, 2014

    Report

    Report Number
    3004209178-2014-08063
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0FQ0M, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    H3. ANALYSIS OF THE INS ((B)(4)) FOUND NO ANOMALY. THE RETURNED INS WAS TESTED WITH A KNOWN GOOD LEAD. THE LEAD PROXIMAL END WAS CONNECTED TO THE INS, WHILE THE LEAD DISTAL END WAS PLACED IN A 0.9% SALINE SOLUTION. USING A CLINICIAN PROGRAMMER, IMPEDANCES WERE MEASURED AND NORMAL IMPEDANCES WERE MEASURED ON ALL CIRCUITS AND ELECTRODE PAIR COMBINATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES DURING A PROCEDURE AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NEVER IMPLANTED. IT WAS NOTED THAT THE INS WOULD BE RETURNED AND WAS REPLACED WITH ANOTHER INS. THE IMPEDANCES WERE GREATER THAN 4000 OHMS. IT WAS REPORTED THAT DIAGNOSTIC TESTING OF IMPEDANCE TESTING WAS DONE. THE PRODUCT ISSUE WAS NOT RESOLVED AND THE CAUSE OF THE ISSUE WAS NOT DETERMINED. IT WAS NOTED THAT THEY CONNECTED THE GENERATOR TO THE LEAD AND RAN THE IMPEDANCE TEST AND GOT GREATER THAN 4000 ERRORS ON THE MAJORITY OF THE ELECTRODES. THEY INCREASED THE AMPLITUDE AND PULSE WIDTH AND RE-RAN THE TEST WITH THE SAME ERRORS. IT WAS REPORTED THAT THEY DISCONNECTED THE LEAD FROM THE GENERATOR AND RECONNECTED THE LEAD TWICE AND STILL RECEIVED THE ERRORS. THE LEAD WAS TESTED WHILE IT WAS DISCONNECTED AND THEY GOT MOTOR AND SENSORY RESPONSES ON ALL ELECTRODES. IT WAS NOTED THAT THEN THEY REPLACED THE GENERATOR. THE PATIENT STATUS WAS ALIVE WITH NO INJURY AND THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE HAD NOT RETURNED THE DEVICE YET AND WOULD RETURN IT BY THE END OF THE WEEK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE RETURNED THE DEVICE 4 DAYS AGO. THE MANUFACTURER REPRESENTATIVE'S SPOUSE WAS SUPPOSED TO SEND IT BUT THE NEVER DROPPED IT OFF FOR THEM. IT WAS NOTED THAT THE DEVICE WAS ON THE WAY AND IT SHOULD BE THERE SOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250016 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR