BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6169275 · Received December 13, 2016

    Report

    Report Number
    3004209178-2016-26317
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    December 12, 2014
    Report Date
    April 5, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1570-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND THAT IT WAS OVER-INFUSING BY MORE THAN 14.5% AT STANDARD TEST CONDITIONS AND TYPICAL THERAPEUTIC RATE (300 UL/DAY) DUE TO AN UNDETERMINED ROOT CAUSE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) ON (B)(6) 2017. THE PREVIOUSLY REPORTED STATEMENT THAT THE PUMP NEEDED TO BE REPLACED TWO YEARS AGO AND WASN¿T WORKING WAS CLARIFIED BY THE HCP THAT IT WAS AT END OF LIFE. REGULAR CHECKS WERE DONE AS TROUBLESHOOTING PERFORMED. THE CAUSE OF THE PUMP WASN¿T WORKING AND NEEDED TO BE REPLACED WAS REPORTED BY THE HCP THAT IT WAS WORKING AND THAT THE PATIENT HAD ¿SUGAR ISSUES¿ SO IT COULD NOT BE REPLACED. THE ISSUES HAD NOT BEEN RESOLVED AS THEY WERE WAITING TO GET THE PUMP REPLACED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER¿S REPRESENTATIVE REGARDING THE PATIENT WHO WAS AT THE TIME OF THE EVENT WAS RECEIVING PRESERVATIVE FREE NORMAL SALINE AT MINIMUM RATE. IT WAS REPORTED ON (B)(6) 2017 THAT THE PUMP WAS REPLACED ON (B)(6) 2017 DUE TO END OF SERVICE (EOS) LIFE OF PUMP AND THAT THE PATIENT REQUESTED THE PUMP BE RETURNED FOR ANALYSIS. IT WAS NOTED THAT THE PATIENT NOTICED A PALPABLE WARMTH OVER HIS SKIN OVERLYING THE PUMP ONE TIME. ANY ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WERE UNKNOWN. NO DIAGNOSTICS OR TROUBLESHOOTING WAS PERFORMED AND NO INTERVE NTIONS/ACTIONS WERE TAKEN TO RESOLVE THE ISSUE. IT WAS INDICATED THAT AT THE TIME OF THE REPORT THE ISSUE WAS RESOLVED AND THE PATIENT STATUS WAS ¿ALIVE ¿ NO INJURY.¿ THE PATIENT MEDICAL HISTORY WAS ASKED AND WOULD NOT BE MADE AVAILABLE DUE TO A LEGAL/CONFIDENTIAL REASON. THE PATIENT WEIGHT WAS ASKED AND WOULD NOT BE MADE AVAILABLE DUE TO A LEGAL/CONFIDENTIAL REASON. OTHER MEDICATIONS THE PATIENT WAS TAKING AT THE TIME OF THE EVENT COULD NOT BE OBTAINED AS THEY WERE NOT AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS RECEIVING BUPIVACAINE AT AN UNKNOWN CONCENTRATION AND DOSE VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME. IT WAS REPORTED ON (B)(6) 2016 THAT WITH THE PUMP THE PATIENT WAS HURTING LESS BUT THE PATIENT HAD THEM REMOVE THE MEDICATION BECAUSE HE THOUGHT HE WAS HAVING A REACTION TO IT. IT WAS INDICATED THAT AFTER THE IMPLANT, (B)(6) 2010, IT STARTED TO BURN WHEN THE PATIENT PEED. THE PATIENT HAD THEM REMOVE THE MEDICATION AND PUT SALINE IN IT. AFTER THAT, THE PATIENT STARTED ¿HURTING¿ AGAIN BUT THE BURNING WENT AWAY. IT WAS NOTED THAT ANY ¿-CAINE¿ MEDICATION GAVE HIM TROUBLE. IT WAS REPORTED THAT PER THE CONSUMER, THE PATIENT¿S HEALTHCARE PROFESSIONAL SAID THE PUMP NEEDED TO BE REPLACED TWO YEARS AGO AND IT WAS NOT WORKING. IT WAS INDICATED THAT THE PATIENT WAS TRYING TO GET THE HCPS TO WORK WITH HIM AND FIND A MEDICATION THAT WOULD WORK. IT WAS NOTED THAT THE PATIENT HAD DIABETES BEFORE THE PUMP AND THAT HE WAS (B)(6) WHEN HE FELL AND SHATTERED A BONE WHICH WAS THE REASON HE GOT THE IMPLANT. THE PATIENT WAS LOSING WEIGHT TO CONTROL HIS DIABETES AND WAS DOWN TO (B)(6). IT WAS NOTED THAT THE PATIENT WAS ¿GOING MORE¿ AND EXERCISING WHICH WAS ANOTHER REASON HE WAS HURTING MORE. NO INTERVENTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821769 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention