BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4140911 · Received October 3, 2014

    Report

    Report Number
    3004209178-2014-18297
    Event Type
    Injury
    Date Received
    October 3, 2014
    Report Date
    September 15, 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
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-28, LOT# VA01ER2, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED SHOCKING AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE. THE ISSUE STARTED TWO MONTHS AGO WHEN THE PATIENT SUFFERED A "SIGNIFICANT" SHOCK TO THEIR BODY. IT WAS NOTED THE PATIENT COULD NOT TURN STIMULATION UP PAST 0.2 V. IMPEDANCES WERE REPORTEDLY "NORMAL." NO OUTCOME OR INTERVENTIONS WERE PROVIDED WITH THIS EVENT. FURTHER FOLLOW UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A COOKING ACCIDENT WHERE SHE ELECTROCUTED HERSELF AND FELL ON HER SIDE WHERE SHE HAD THE IMPLANT. FOLLOWING THE EVENT, THE PATIENT'S BATTERY AND ENTIRE SYSTEM WAS NOT WORKING APPROPRIATELY AND THE DEVICE BEGAN MALFUNCTIONING. THE DEVICE WAS DISTURBED, WAS WORKING IN AN AWKWARD FASHION, AND FAILED. PRIOR TO THE ACCIDENT, THE PATIENT HAD SIGNIFICANT BENEFITS FROM THE DEVICE, AND NOW SHE WASN'T IN "GOOD SHAPE" AND FELT FUNNY SENSATIONS HERE AND THERE IF SHE TURNED IT UP. THE PATIENT KEPT THE DEVICE AT 0.2 AMPERES AND THIS GAVE HER SOME BENEFIT WITHOUT UNPLEASANT EFFECTS, BUT ONCE THE AMPLITUDE WAS INCREASED, SHE GOT THAT. COMPLEX PROGRAMMING WAS PERFORMED AND SHE WAS ON PROGRAM 1 AT 0.2 AMPERES. THE BATTERY LIFE WAS AT 101.2 MONTHS. ELECTRODE IMPEDANCES WERE "CORRECTED" AND IMPEDANCES WERE GREATER THAN 50 AND LESS THAN 4000 ON ALL SETTINGS. THE DEVICE WAS TESTED IN THE OFFICE AND PROGRAMMED, AND THE RESPONSES WERE NOT APPROPRIATE. BECAUSE OF THE "ABNORMAL SHOW SENSATIONS AND RESPONSES" AND CLINICAL HISTORY, THE PATIENT'S HEALTHCARE PROVIDER DISCUSSED REVISING THE DEVICE WITH THE PATIENT. THE HEALTHCARE PROVIDER FIRST TRIED TO JUST CHANGE THE BATTERY; HOWEVER, THE PATIENT'S RESPONSES WERE NOT APPROPRIATE DURING THE SURGERY AND THE HEALTHCARE PROVIDER DECIDED TO DO A TOTAL COMPLETE REVISION WHICH INCLUDED REMOVING THE TINED LEADS AND BATTERY AND DOING A FULL IMPLANT AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618508 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention