BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2862189 · Received December 7, 2012

    Report

    Report Number
    3004209178-2012-11280
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Report Date
    November 7, 2012
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709SC LOT# N172757013, IMPLANTED: 2009 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A VOLUME DISCREPANCY AND THE PATIENT WAS EXPERIENCING "VIBRATIONS" OF HIS BODY FROM THE PUMP. THE PATIENT STATED THAT "THE PUMP IS NOT WORKING, IT QUIT WORKING 2 OR 3 MONTHS AGO". THE PATIENT FURTHER REPORTED THAT THE PUMP STILL CONTAINS MEDICATION, ALTHOUGH IT IS "NOT DELIVERING MUCH DRUG". ON (B)(6) 2012, THE HEALTHCARE PROVIDER (HCP) CHECKED THE PUMP AND FOUND 37ML FOR AN ACTUAL VOLUME, WHEN 3 MONTHS BEFORE THAT "THEY PUT 41ML IN IT". OVER THE THREE MONTH PERIOD, THE PUMP HAD ONLY DELIVERED APPROXIMATELY 4ML. THE DOSE AND DAILY RATE WERE NOT PROVIDED. THE PATIENT ALSO REPORTED THAT THE PUMP WAS "MAKING HIS ENTIRE BODY VIBRATE", WHICH GAVE THE PATIENT CONCERN THAT THE PUMP WAS GOING "TO DO DAMAGE TO MY INSIDES". THE PATIENT FELT THE VIBRATION 90% OF THE TIME, THOUGH IT OCCURS INTERMITTENTLY, STOPPING AND THEN STARTING AGAIN. THE VIBRATION STARTED APPROXIMATELY ONE MONTH PRIOR TO THE REPORT DATE. THE HCP DID NOT KNOW WHAT THE VIBRATION COULD BE, PER THE REPORTER. THE PATIENT NOTED THAT THE HCP CHECKED THE PUMP "WITH A MACHINE AND EVERYTHING ELSE". IT WAS NOT CLEAR IF/OR WHAT TESTING WAS DONE. THE PATIENT ANTICIPATED ANOTHER APPOINTMENT WITH THE HCP ON (B)(6) 2012. THE HCP AND PATIENT DESIRED A PUMP REMOVAL, HOWEVER, THE INSURANCE COMPANY WAS NOT APPROVING THE PROCEDURE BECAUSE OF THE BELIEF THE PUMP IS BETTER FOR THE PATIENT THAN THE ORAL MEDICATIONS. THE PATIENT INDICATED THERE WERE COURT PROCEEDINGS WHICH WERE TO OCCUR WITH THE INSURANCE COMPANY. IT WAS LATER REPORTED BY THE HCP THAT THE CAUSE OF THE VOLUME DISCREPANCY WAS UNKNOWN. THE HCP NOTED THERE WAS A VOLUME DISCREPANCY AND THEY WERE STILL AWAITING EXPLANT. THERE HAD BEEN NO OCCURRENCE OF SURGICAL INTERVENTION, AND NO HOSPITALIZATION. PER THE HCP CLINIC VISIT NOTES, THE PATIENT WAS EXPERIENCING KNEE, BACK AND LEG PAIN, WHICH WAS WORSE. THE PATIENT OUTCOME WAS REPORTED AS NO INJURY. THE MEDICATIONS IN THE PUMP WERE FENTANYL, BACLOFEN, AND CLONIDINE <(>&<)> BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. PATIENT CONTINUED TO REPORT PUMP VIBRATION AND PUMP NOT WORKING. PATIENT INDICATED THE WORKERS COMP ATTORNEY WENT TO COURT AND TOLD THE PATIENT'S ATTORNEY THAT THERE WAS NOTHING WRONG WITH THE PUMP "EVEN THOUGH NOBODY'S LOOKED AT IT". PATIENT STATED 3 MONTHS AGO THEY PUT 41MLS IN THE PUMP AND AS OF LAST MONTH THERE WERE 34 MLS STILL IN THERE AND IT SHOULD HAVE BEEN CLOSE TO EMPTY. PATIENT INDICATED HE WAS TRYING TO HAVE THE PUMP REMOVED BECAUSE IT WASN'T WORKING RIGHT, BUT THE INSURANCE COMPANY WAS SAYING ONE THING AND THE DOCTOR'S OFFICE IS SAYING SOMETHING ELSE AND HE WAS GETTING THREE DIFFERENT ANSWERS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1