BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3902366 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12266
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER ANALYSIS REVEALED THERE WAS A SOLDER BRIDGING ON THE PUMP.

    Additional Manufacturer Narrative · 1

    FURTHER ANALYSIS CONFIRMED CURRENT DRAIN ANOMALY. BOTH THE HYBRID REGULATED SUPPLIES, AND THE IBIAS WERE BELOW NOMINAL. MULTIPLE SOLDER BUMP ANOMALIES WERE IDENTIFIED ON ALL THREE HYBRID IC¿S. HOWEVER, DUE TO THE LIMITED RESOLUTION OF THE X-RAY, NO DISTINCT ELECTRICAL SHORTS WERE IDENTIFIED. RESULTS OF TESTING CONFIRMED THAT THE CAUSE OF THE REPORTED, AND OBSERVED, CURRENT DRAIN ANOMALIES WERE DUE TO A FAULT IN THE L334. THE ANALYSIS RESULTS WERE CONSISTENT WITH THE REPORTED FAILURE MODE BEING CAUSED BY THE SHORTING OF ADJACENT SOLDER BUMPS ON THE L334.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED TO UPDATE EVALUATION SUMMARY. AN ANOMALY OF THE HYBRID WAS FOUND. AFTER APPROXIMATELY 2 YEARS OF SERVICE THIS PUMP MET VOLTAGE TRIP POINT FOR EOS (2.60V). STATIC CURRENT DRAIN WAS FOUND TO BE A FAILING 59.6 UA.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ALARM WAS HEARD AND ALSO CONFIRMED BY TELEMETRY. IT WAS NOTED THE TELEMETRY CONFIRMED A NON-CRITICAL ALARM WAS OCCURRING AND THE ALARM WAS DUE TO THE ELECTIVE REPLACEMENT INDICATOR (ERI). THE HEALTHCARE PROVIDER (HCP) WAS CALLED OVER THE WEEKEND BECAUSE THE PATIENT¿S PUMP WAS ALARMING AND THE PATIENT WAS SEEN IN THE CLINIC ON THE DATE OF THIS REPORT. THE PUMP STATUS SHOWED THAT ERI OCCURRED (B)(6) 2014 AND THE PATIENT DID NOT HEAR THE ALARM INITIALLY. THE PATIENT WAS SEEN ON (B)(6) 2014 FOR A REFILL AND THE ERI AT THAT TIME WAS 54 MONTHS. THE PUMP LOGS SHOWED NO OTHER ALARMS AT THIS TIME. THE PUMP WAS BEING USED TO DELIVER MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PUMP WAS REPLACED ON (B)(6) 2014 AND WOULD BE RETURNED. THE REPLACEMENT WAS DUE TO PREMATURE BATTERY DEPLETION AND FURTHER TROUBLESHOOTING/TESTING WAS NOT REQUIRED. THE PATIENT HAD HEARD BEEPING, CAME INTO THE OFFICE, AND WHEN INTERROGATED THE ELECTIVE REPLACEMENT INDICATOR (ERI) HAD OCCURRED ON (B)(6) 2014. THE PATIENT WAS NOT ON ANY ORAL MEDICATIONS. THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT WAS ¿ALIVE-NO INJURY.¿ THERE WERE NO SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE PATIENT WAS DOING ¿FINE.¿

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT'S PAIN PUMP WENT BAD EARLY AFTER 2.5 YEARS. THE PATIENT DESCRIBED THE PUMP AS "SWITCHING OVER" AND "SAID IT NEEDED TO BE REPLACED". THE PUMP KEPT ALARMING AND CAUSED THE PATIENT TO START HAVING MIGRAINES ABOUT A WEEK AFTER THE ALARM STARTED AND THE MIGRAINES LASTED FOR OVER A MONTH. THE PATIENT WAS GETTING 3-4 MIGRAINES PER WEEK AND HAD TO GO TO THE EMERGENCY ROOM (ER). THE PATIENT WENT TO THE EMERGENCY ROOM (ER) 3 OR 4 TIMES FOR THE MIGRAINES BETWEEN MAY AND AUGUST. LATER THE PATIENT REPORTED THAT THE MIGRAINE HEADACHES WERE NOT AS BAD AND HAS ONLY HAD 1-2 HEADACHES SINCE THEN. THE PATIENT HAD ADDITIONAL TESTS AND APPOINTMENTS AS A RESULT OF THE MIGRAINES. THE PATIENT WAS REALLY SICK AND NAUSEATED FROM MAY UNTIL THE PUMP WAS REMOVED. OTHER MEDICATION (ORAL, ETC) THE PATIENT WAS TAKING INCLUDED STAZOL NASAL SPRAY. THE PATIENT WAS TAKING HYDROCODONE BUT WAS"EATING THEM LIKE CANDY" SO THE PATIENT WAS PUT ON THE STAZOL. AT THE TIME OF REPORT THE PATIENT'S NEW PUMP WAS DOING GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379007 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention