BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2390091 · Received December 28, 2011

    Report

    Report Number
    3004209178-2011-10088
    Event Type
    Injury
    Date Received
    December 28, 2011
    Report Date
    December 5, 2011
    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

    ANALYSIS OF THE PUMP REVEALED NO ANOMALY; NORMAL DEVICE FUNCTION. ON RECEIVING THE INITIAL PUMP, PRINT OUT SHOWED MULTIPLE STALLS AND RECOVERIES THAT OCCURRED ON (B)(4) 2011 (24 MINUTES), (B)(4) 2011 (41 MINUTES), (B)(4) 2011 (40 MINUTES), (B)(4) 2011 (26 MINUTES), (B)(4) 2011 (40 MINUTES), (B)(4) 2011 (20 MINUTES), (B)(4) 2011 (34 MINUTES), (B)(4) 2011 (16 MINUTES), (B)(4) 2011 (53 MINUTES), (B)(4) 2011 (9 MINUTES), AND (B)(4) 2011 (16 MINUTES). ON ITS ARRIVAL, NO ADDITIONAL STALLS HAD OCCURRED. PUMP PASSED ALL TESTING. THE PUMP COMPONENTS APPEARED VERY CLEAN WITH NO APPARENT DEFECTS AND ONLY VERY SLIGHT EVIDENCE OF CORROSION DURING TESTING. ADDITIONAL ANALYSIS SHOWED NO ANOMALIES IN HYBRID PERFORMANCE AND IT WAS CONCLUDED THAT A ROOT CAUSE FOR THE STALLS AND RECOVERIES COULD NOT BE LINKED TO ANY PUMP ANOMALY.

    Additional Manufacturer Narrative · 1

    CATHETER MODEL #: 8709SC, LOT #: N297352009, IMPLANTED: (B)(6) 2011, EXPLANTED: UNKNOWN.

    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.

    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 LATER REPORTED THAT THE "FIRST PUMP WAS EXPLANTED AFTER A FEW MONTHS FOR THE SAME ISSUE AND AFTER IT WAS EXPLANTED, IT STARTED WORKING NORMALLY AGAIN".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CONFIRMED MOTOR STALLS AND MOTOR STALL RECOVERIES WERE RECORDED IN THE PUMP EVENT LOGS SINCE (B)(6) 2011. THE PUMP CONTAINED MORPHINE 10 MG/ML. A PATTERN WAS NOTED IN THE TIME-OF-DAY OF THE STALLS. THE PATIENT WAS 'ADAMANT' THAT SHE HAD NOT BEEN IN CLOSE PROXIMITY TO MAGNETIC SOURCES. PER THE REPORTER, 'THE PUMP OPERATES FOR APPROXIMATELY TWENTY-THREE HOURS EACH DAY, PRESUMABLY DELIVERING APPROXIMATELY 96% OF THE PRESCRIBED MEDICATION'. THE PATIENT REPORTED FREQUENT "BEEPING", NAUSEA AND IRRITABILITY. REPLACEMENT SURGERY WAS SCHEDULED FOR (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PUMP WAS REPLACED. IT WAS REPORTED THAT PATIENT EXPERIENCED SLIGHT WITHDRAWAL SYMPTOMS; NO ROTOR, CATHETER DYE STUDIES WERE DONE. DRUG DELIVERED VIA THE DEVICE WAS MORPHINE 10MG/ML AT A DAILY DOSE OF 2MG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention