BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3840311 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09863
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 7, 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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# J0504288V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WORKED ¿AWESOME¿ FOR YEARS BUT THEN IN (B)(6) 2014, THE DEVICE SLOWLY STOPPED WORKING (¿GRADUALLY¿). THE PATIENT HAD ¿ZERO¿ SENSATION AND ¿ZERO¿ RESPONSE. IT WAS NOTED THAT THE PATIENT USED HIGHER VOLTAGES SUCH AS 3 OR 3.5 VOLTS DAILY. THE HEALTHCARE PROFESSIONAL (HCP) STATED THAT IT ¿SOUNDS LIKE A DYING BATTERY¿ TO THEM. THE PATIENT STATED THAT THE INS WOULD TURN ITSELF OFF AND THEY WERE WELL VERSED WITH THE DEVICE. THE HCP HAD TROUBLE GETTING THE INS TO RESPOND AND WAS TURNING OFF. THE CLINICIAN PROGRAMMER SHOWED 80-81 MONTHS. THE HCP STATED THAT, EVEN IF THE LEAD WAS IN THE WRONG PLACE OR MIGRATED, THE PATIENT SHOULD FEEL SOMETHING AT 3.5 VOLTS. THE HCP ALSO NOTED THAT MOST PATIENTS ARE PROGRAMMED SOMEWHERE BETWEEN 0.7 AND 1.1 VOLTS NORMALLY. IMPEDANCES WERE CHECKED AT 1.0 VOLTS, 210 PW AND ELECTRODES #0 <(>&<)> 2 SHOWED VALUES OF >4000 OHMS. THE IMPEDANCE CHECK WAS RE-RUN AT 1.5 VOLTS AND VALUES RANGED FROM 319 TO 1679 OHMS. IT WAS CONFIRMED THAT THE PATIENT ¿CAN¿T FEEL ANYTHING¿ AND THAT THE HCP HAD NOT TRIED TO REPROGRAM THEM. IT WAS NOTED THAT THE PATIENT¿S PROGRAMMING WAS ¿ALL OVER THE BOARD¿ AND THE ¿PATIENT FEELS NOTHING¿. THE HCP STATED THAT THE DEVICE WAS BEHAVING ¿LIKE IT IS A SLOWLY DYING BATTERY LIKE WHAT SHE WOULD SEE AT EOL¿ (END-OF-LIFE). IN ADDITION, THE HCP NOTED THAT THEY WILL MOST LIKELY HAVE TO BRING THE PATIENT BACK AND TEST THE LEADS INTRA-OPERATIVELY TO SEE WHAT IS GOING ON. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318128 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention