BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3151067 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-08760
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 15, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION MADE TO UPDATE THE PREVIOUSLY REPORTED CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8590-1, LOT# N303824, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8840, PRODUCT TYPE PROGRAMMER, PHYSICIAN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 8 590-1, LOT# N303824, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. PRODUCT ID: NEU_PTM_PROG, PRODUCT TYPE: PROG RAMMER. PATIENT PRODUCT ID: NEU_UNKNOWN_PROG, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PUMP WAS WORKING FINE BUT THE PATIENT NEEDED THE PUMP TURNED UP A LITTLE BIT. THE PTM BOLUS DEVICE WAS WORKING NOW. IT WAS FURTHER NOTED THE PATIENT WAS DIAGNOSED WITH CANCER AND LOST ¿ALL HIS UPPER TEETH¿. THE CANCER WAS UNRELATED TO THE PUMP.THE PUMP WAS USED TO DELIVER DILAUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD RECEIVED TWO PERSONAL THERAPY MANAGER (PTM) REPLACEMENTS AND NEITHER OF THE TWO PTMS WERE ABLE TO READ THE PUMP. THE PATIENT WAS CONCERNED THAT IT MAY BE THE PUMP RATHER THAN THE PTMS. THE PATIENT REPORTED THAT THERE WAS AN ¿X¿ ON THE SCREEN WHEN TRYING TO COMMUNICATE WITH THE PUMP. WHEN THE PATIENT FIRST TURNED ON THE PTM THERE WAS PICTURE OF A FINGER POINTING TO THE SELECTOR KEY AND A PICTURE OF THE PTM WITH A CHECK BOX IN THE LOWER LEFT CORNER. THIS HAD OCCURRED BOTH WITH AND WITHOUT ANTENNA USE. TROUBLESHOOTING WAS NOT SUCCESSFUL IN THE PAST. UPON ATTEMPTING AGAIN THE PATIENT REPORTED THAT YELLOW LIGHT WAS BLINKING AND THEN IT DISPLAYED THE PTM, AN ¿X¿ AND WHAT LOOKS LIKE A SPOOL OF WIRE. A CHECK MARK IN A BOX IN THE LOWER LEFT AND A TRIANGLE IN THE UPPER LEFT CORNER WERE ALSO PRESENT. THE PATIENT DENIED BEING NEAR ENVIRONMENTAL INTERFERENCES AND DENIED CHANGES IN THE POSITION OF THE IMPLANTED PUMP. THE PATIENT¿S PUMP AT ONE POINT HAD BEEN RE-SEWN DUE TO PUMP MOVEMENT (SEE MANUFACTURE REPORT # 3004209178-2013-08759) BUT ¿THAT DIDN¿T EVEN MAKE IT NOT COMMUNICATE. IT STILL WORKED.¿ THE PATIENT WAS RECENTLY HOSPITALIZED, UNRELATED TO THE PUMP, FOR A TUMOR ON HIS ADRENAL GLAND. REPORTEDLY, THIS DEVICE SYSTEM DELIVERED DILAUDID AND A ¿MUSCLE RELAXER.¿ IT WAS FURTHER REPORTED THAT THE PATIENT HAS NOT HAD AN OPERATING PTM IN ALMOST A MONTH¿S TIME. TROUBLESHOOTING ATTEMPTS WERE AGAIN MADE OVER THE PHONE WITH TECHNICAL SERVICES AND THE PATIENT STILL HAD THE SAME ISSUES. THE PATIENT HAD ALSO REPORTED THAT AT ONE TIME THE PHYSICIAN ¿HAD TROUBLE READING IT WITH HIS MAIN UNIT BEFORE.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION HAD BEEN RECEIVED. IT WAS REPORTED THAT THE PERSONAL THERAPY MANAGER (PTM) WAS BROKEN. THE BATTERIES HAD BEEN CHANGED TWO TIMES, BUT THE SCREEN WAS NOT WORKING OR DOING ANYTHING. THE ISSUE HAD BEEN OCCURRING ON AND OFF FOR ABOUT A WEEK. IT WAS ALSO NOTED THAT THE PTM HAD NOT GOTTEN WET. IT WAS ALSO REPORTED THAT THE PTM WOULD NOT WORK WITH EITHER ANTENNA. THERE WAS NO PATIENT HARM REPORTED. SIX DAYS LATER, IT WAS REPORTED THAT THE PTM HAD QUIT WORKING. IT HAD REPORTEDLY KEPT DOING ¿DIFFERENT THINGS¿ UNTIL IT QUIT ALTOGETHER. IT WAS LATER REPORTED THAT THE PTM¿S DIGITAL BOARD NEEDED TO BE REPLACED DUE TO A COMPONENT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251593 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1