BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4060189 · Received September 4, 2014

    Report

    Report Number
    3004209178-2014-16369
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Report Date
    August 11, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS SEEN BY THE HEALTHCARE PROVIDER (HCP) ON (B)(6) 2014 AND THE PATIENT¿S PUMP WAS DETERMINED TO BE EMPTY SINCE (B)(6) 2014. THE PUMP WAS FILLED WITH 10 MILLILITERS (ML) OF SALINE AND CONTINUED AT THE SAME RATE THE PUMP WAS PROGRAMMED. THE PUMP WAS INTERROGATED ON (B)(6) 2014 AND SHOWED NO NEW ALARMS AND THE HCP DECIDED TO REFILL THE PUMP ON (B)(6) 2014 AND RESTART THERAPY WITH THE PATIENT. PATIENT SYMPTOMS WERE NOT REPORTED WITH THIS EVENT AND IT WAS UNKNOWN WHAT DRUG THE PUMP WAS BEING USED TO DELIVER. IT WAS FURTHER REPORTED THE NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI) OCCURRED; HOWEVER IT WAS UNCLEAR IF THIS WAS CORRECTLY REPORTED. ALSO, OUTCOME OR DRUG WERE NOT REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THE PATIENT HAD SOME MINOR WITHDRAWAL SYMPTOMS THOUGH THE REPORTER DID NOT KNOW THE EXACT WITHDRAWAL SYMPTOMS. THE ERI WAS NORMAL. THE PUMP WAS EMPTY FOR 6 MONTHS DUE TO THE PATIENT CHOOSING NOT TO GO IN TO THE OFFICE. THE PATIENT WAS NON-COMPLIANT. THE HCP PUT SALINE IN THE PUMP AND RAN IT FOR A WEEK TO TEST PUMP FUNCTIONALITY. HE BROUGHT THE PATIENT BACK A WEEK LATER AND CHECKED VOLUME. THE PUMP WAS STILL FUNCTIONING. THE PHYSICIAN THEN PERFORMED A CAP STUDY AND THE CATHETER WAS WORKING AS WELL. THE PHYSICIAN FILLED THE PUMP WITH DILAUDID AND STARTED AT A LOW DOSE WITH THE INTENTION OF TITRATING BACK UP INCREMENTALLY. THE PATIENT WAS DOING WELL AND RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541078 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR