BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4961613 · Received August 3, 2015

    Report

    Report Number
    3004209178-2015-14539
    Event Type
    Injury
    Date Received
    August 3, 2015
    Date of Event
    September 17, 2012
    Report Date
    February 21, 2017
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. PRODUCT ID: 8 591-38, LOT# D17878, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    PUMP ANALYSIS RESULTS REVEALED OVERINFUSION WITH AN UNDETERMINED ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    THIS PUMP WAS SUBJECTED TO OI CAPA TESTING. THE PUMP LOGS WERE FREE FROM ANY ANOMALIES, THEREFORE NOT REQUIRING THIS PUMP TO BE PUT THROUGH FULL DESTRUCTIVE ANALYSIS AS PER LAB PROCESS. ANALYSIS IS COMPLETE. 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

    IT WAS REPORTED THE PATIENT FELT THE PUMP WAS NOT WORKING AND DIDN'T WANT IT ANYMORE. THE PUMP HAD HELPED THE PATIENT'S LEG, BUT IT HADN'T HELPED HIS ARM BE LOOSER. THE THERAPY COMPLAINT HAD BEEN GOING ON SINCE IMPLANT. THE PATIENT EXPERIENCED GOOD RESULTS FROM THE TRIAL AND EXPECTED THE SAME EFFECT FROM THE PUMP. HE DID NOT GET THE EXPECTED RESULTS FOR HIS ARM. IT WAS LATER REPORTED THE PATIENT'S HEALTHCARE PROVIDER (HCP) HAD BEEN TITRATING THE PATIENT DOWN 20% AT VISITS AND THE PATIENT SHOWED NO SYMPTOMS OF WITHDRAWAL/UNDERDOSE. THE HCP PLANNED TO GET THE PUMP DOWN TO 0 AND PUT THE PATIENT ON ORAL MEDICATION. THE HCP DOESN'T THINK THIS THING IS CONNECTED AND THAT'S WHY THE PATIENT HASN'T HAD GOOD THERAPY. THE TYPE OF MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE CAUSE AND DIAGNOSTICS, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE INDICATED THAT NEITHER A DYE STUDY NOR A ROTOR STUDY WAS PERFORMED. THE PUMP WAS EXPLANTED ON (B)(6) 2015. THE PATIENT RECOVERED WITHOUT SEQUELA AFTER THE DEVICE WAS REMOVED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REPORTING THEY HAD REFILLED THE PATIENT'S PUMP WITH SALINE. AT FIRST, THE HCP WAS HAVING DIFFICULTIES WITH PROGRAMMING THE PUMP; HOWEVER, SHE WAS JUST UNFAMILIAR WITH HOW TO CHANGE THE DRUG NAME AND CONCENTRATION UNITS. THE PUMP WAS PROGRAMMED TO SALINE AT 1 ML/ML AND MINIMUM RATE MODE. THE PATIENT MAY POSSIBLY GET THE PUMP REMOVED IN A FEW WEEKS. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER WHO CLARIFIED THAT IN REFERENCE TO THE STATEMENT "DOESN'T THINK THAT THIS THING IS CONNECTED," WAS ONLY TRYING TO UNDERSTAND THE THERAPY AND THINKING OUT LOUD AS TO WHY IT WAS NOT WORKING IN ONE AREA AND NOT THE OTHER. THE DEVICE WAS NOT BEING REFERENCED. THE PATIENT WAS DOING FINE AND HAD DECIDED TO HAVE THE PUMP REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505842 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00023 YR Required Intervention