BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3952420 · Received July 23, 2014

    Report

    Report Number
    3007566237-2014-02054
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. THE EVENT IS NO LONGER CONSIDERED A SERIOUS INJURY SINCE THE PLANNED REPLACEMENT NEVER TOOK PLACE AND THE ISSUE RESOLVED WITH REPLACING THE PATIENT PROGRAMMER. THE INITIAL MDR WAS FILED AS MFR. REPORT # 3007566237. ADDITIONAL REVIEW SHOWED THE CORRECT MANUFACTURING SITE WAS SITE # 3004209178.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ERROR CODE 304 WAS SEEN ON THE PATIENT PROGRAMMER. THE ERROR CODE APPEARED WITH THE ¿CALL YOUR DOCTOR¿ ICON. IT WAS STATED THAT THE PATIENT FELL AND HIT THE IMPLANTABLE NEUROSTIMULATOR (INS) AREA. AFTER THE ACCIDENT, THE ERROR MESSAGE APPEARED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ISSUE WAS NOT RESOLVED FOR VARIOUS REASONS. IT WAS STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT REPLACED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT INSPECTION OF THE PATIENT PROGRAMMER FOUND THAT THE DIGITAL BOARD WAS DEFECTIVE/NOT AVAILABLE. THE CAUSE WAS NOTED TO BE A SYSTEM ERROR. THE PROGRAMMER WAS SCRAPPED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REPLACING THE PROGRAMMER RESOLVED THE ISSUE. THE PATIENT WENT BACK HOME HAPPY. THE INS WOULD NOT BE REPLACED AS PREVIOUSLY REPORTED, SINCE IT WAS DETERMINED THAT THERE WAS NO INS FAILURE.

    Description of Event or Problem · 1

    IT WAS CLARIFIED APPROXIMATELY 3 WEEKS LATER THAT THE PATIENT COULD NOT COMMUNICATE WITH THE INS AFTER A FALL. THE NURSE HAD ALSO TRIED TO COMMUNICATE WITH THE CLINICIAN PROGRAMMER, BUT ONLY RECEIVED THE 304 ERROR CODE. IT WAS THE UNDERSTANDING OF THE MANUFACTURER REPRESENTATIVE THAT THE INS WAS DAMAGED, NOT THE PROGRAMMER; AS THERE WAS NO COMMUNICATION BETWEEN BOTH PROGRAMMERS. IT WAS REPORTED APPROXIMATELY A MONTH LATER THAT THE SITUATION HAD BEEN UNCHANGED SINCE JULY 2014. THE PATIENT'S SYMPTOMS REAPPEARED. THE NURSE CONFIRMED THAT THE PATIENT OR CLINICIAN PROGRAMMERS COULD NOT CONNECT WITH THE INS. IT WAS STATED THAT THE INS BATTERY WAS CHECKED DURING A (B)(6) 2014 VISIT AND THE LIFE WAS ESTIMATED TO LAST UNTIL THE FALL/WINTER OF 2014/2015. THE PATIENT HAD NOT RECEIVED STIMULATION/MODULATION SINCE THE FALL. THE CLINIC MET WITH THE PATIENT FOR THE FIRST TIME 2 WEEKS AFTER THE FALL AND A BATTERY CHANGE WAS SCHEDULED FOR (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430036 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention