BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3240251 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12078
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO CONTROL HER INTERSTIM II BATTERY BECAUSE UPON SYNCING, HER ICON DISPLAYED THE SCREEN SHOWN IN THE SECOND PICTURE (PICTURE OF POR - POWER ON RESET - MESSAGE). WHEN TRYING TO USE THE N'VISION TO MAKE ADJUSTMENTS, THE MANUFACTURER'S REPRESENTATIVE WAS REQUESTED TO INPUT THE MISSING NUMERICAL DIGITS FROM THE INTERSTIM'S SERIAL NUMBER, ALTHOUGH IT WAS THE LETTERS THAT WERE MISSING, NOT THE NUMBERS. HOWEVER, ONLY SIX DIGITS IN TOTAL COULD BE INPUT, SO IT WAS NOT ACTUALLY POSSIBLE TO RECORD THE WHOLE SERIAL NUMBER. THIS HAPPENED TWO MONTHS AGO, BUT THE HCP (HEALTHCARE PROVIDER) PROGRAMMING THAT DAY MANAGED TO SKIP TO THE NEXT SCREEN AND ICON CONTROL OF THE PATIENT'S INTERSTIM WAS RESUMED. BUT ON THE DAY OF REPORTING THIS WAS NOT POSSIBLE . THE PATIENT HAD TO LEAVE WITHOUT BEING ABLE TO CONTROL HER BATTERY, ALTHOUGH SHE DID RETURN TO THE HOSPITAL (B)(6) 2013 FOR A SEPARATE OPERATION AND THE PATIENT WAS SEEN BEFOREHAND TO TURN THE BATTERY OFF USING THE N'VISION. THE PATIENT WAS DUE TO BE SEEN AGAIN POST-OPERATIVELY TO TURN HER INTERSTIM BACK ON. THE PATIENT'S INTERSTIM WAS REGISTERING AS LOW BATTERY, BUT DISPLAYED NO MONTHLY FIGURE FOR HOW LOW. ON (B)(6) 2013 ERROR MESSAGE ON HAND HELD CONTROLLER - CONTACT DOCTOR. PROGRAMMER DID NOT RECOGNISE SERIAL NUMBER. BATTERY WAS OK AND THEY MANAGED TO GET WORKING AGAIN. ON (B)(6) 2013 ERROR MESSAGE ON HAND HELD CONTROLLER - CONTACT DOCTOR. PROGRAMMER DID NOT RECOGNISE SERIAL NUMBER. BATTERY WAS LOW. THEY COULD USE HANDHELD CONTROLLER TO TURN SNS DEVICE ON BUT NOT OFF. IT WAS ALSO NOTED THAT THE PATIENT HAD HAD SEVERAL PROGRAMMES, WITH LEVELS OF STIMULATION OF UP TO 4V, ALTHOUGH SOME PROGRAMMES HAD BEEN MUCH LOWER; THE EXACT DETAILS OF ALL PROGRAMMES HAD NOT BEEN RECORDED. POTENTIAL ACTIONS WAS NOTED AS: EXPLANT OF NEUROSTIMULATOR. PATIENT OUTCOME WAS NOTED AS: REDUCED CONTROL OF NEUROSTIMULATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT STILL HAD LIMITED CONTROL THE IMPLANTABLE NEUROSTIMULATOR (INS). THESE WERE THE ENTRIES THE HCP (HEALTHCARE PROVIDER) MADE IN THE PATIENT FILE WITH REGARDS TO HER SNS REPROGRAMMING: (B)(6) 2013 ERROR MESSAGE ON HAND HELD CONTROLLER - CONTACT DOCTOR. PROGRAMMER DOES NOT RECOGNISE SERIAL NUMBER. BATTERY OK. MANAGED TO GET WORKING AGAIN. (B)(6) 2013 ERROR MESSAGE ON HAND HELD CONTROLLER - CONTACT DOCTOR. PROGRAMMER DOES NOT RECOGNISE SERIAL NUMBER. BATTERY LOW. CAN USE HANDHELD CONTROLLER TO TURN SNS DEVICE ON BUT NOT OFF. THE PATIENT CANNOT SYNC THEIR ICON WITH THEIR BATTERY, ADJUST AMPLITUDE OR SWITCH BETWEEN PROGRAMMES, ONLY TURN IT ON (IF IT HAS TURNED OFF). THERE ARE NO PRINT-OUTS AND THERE WASN'T AN OOR MESSAGE. A POR MESSAGE WAS SHOWN ON THE ICON. THE BATTERY GAVE THE LOW BATTERY MESSAGE ON THE 8840. THEY WERE AWAITING THE HEALTHCARE PROVIDER TO RETURN FROM AN ANNUAL LEAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339660 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1