BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2710246 · Received August 22, 2012

    Report

    Report Number
    3004209178-2012-07222
    Event Type
    Injury
    Date Received
    August 22, 2012
    Report Date
    August 1, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL ANALYSIS OF THE PUMP FOUND NO PUMP ANOMALY. THIS PUMP WAS RETURNED TO ANALYSIS WITH THE ALLEGATION OF "PATIENT'S PUMP WAS REMOVED AND REPLACED DUE TO PATIENT COMPLAINT OF NOT GETTING PAIN RELIEF." INITIAL PRINT OUT SHOWS THREE STALLS AND STALL RECOVERIES OCCURRING; (B)(6) 2012 (59 MINUTES), (B)(6) 2012 (33 MINUTES), AND (B)(6) 2012 (53 MINUTES). NOTE THAT STALLS ARE ALL ARE RELATIVELY SHORT IN DURATION. ADDITIONAL TROUBLE SHOOTING WAS PERFORMED WHERE PUMP WAS PROGRAMMED TO A THERAPEUTIC RATE AND LEFT TO RUN IN A BODY TEMP OVEN FOR 1 MONTH. NO ADDITIONAL STALLS OCCURRED DURING THIS TIME. PUMP PASSED ALL NON-DESTRUCTIVE TESTING INCLUDING FLOW TESTING. TECHNICIAN NOTED DURING INITIAL DESTRUCTIVE ANALYSIS THAT PUMP CONTAINED SLIGHT NON-SIGNIFICANT CORROSION. FINAL DESTRUCTIVE ANALYSIS WAS PERFORMED AND PUMP COMPONENTS WERE THOROUGHLY INSPECTED SHOWING NO ADDITIONAL SIGNIFICANT ANOMALIES TO BE DETERMINED AS THE ROOT CAUSE FOR THE FIELD STALLS AND RECOVERIES.

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8703W LOT# L78426, IMPLANTED: 2000 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID, 8575 LOT# J12069R, IMPLANTED: 2005 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CHANGE IN THERAPEUTIC EFFECT AND THE PUMP WAS REPLACED. REPORTER STATED THAT THE PATIENT WAS NOT GETTING PAIN RELIEF FOR SEVERAL MONTHS AND "CALLED THE DR. EVERY DAY FOR DAYS AND DAYS" BECAUSE THEY THOUGHT SOMETHING WAS WRONG WITH THE PUMP AND WANTED IT REPLACED. THE PUMP EVENT LOGS WERE NORMAL, AND A CATHETER DYE STUDY DONE APPROX. 1 MONTH PRIOR TO REPORT DATE WITH NORMAL RESULTS. THE PUMP WAS REPLACED ON (B)(6) 2012. AT THE TIME OF REPLACEMENT, IT WAS NOTED THAT THE EXPECTED RESERVOIR VOLUME (ERV) WAS 5.6ML AND THE ACTUAL RESERVOIR VOLUME (ARV) WAS 5.2ML. WHEN THE CATHETER WAS DISCONNECTED FROM THE PUMP, CATHETER ASPIRATION WAS EASILY PERFORMED; PATENCY WAS CONFIRMED AS WAS THE LOCATION IN THE INTRATHECAL SPACE. THE HEALTHCARE PROVIDERS DID NOT BELIEVE THERE WAS ANYTHING WRONG WITH THE PUMP, BUT REPLACED IT BECAUSE OF THE PATIENT'S CONTINUED REQUESTS. THE PATIENT'S OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELA. THE MEDICATION IN THE PUMP WAS FENTANYL AND BUPIVACAINE.

    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 00051 YR Required Intervention