BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2223867 · Received August 18, 2011

    Report

    Report Number
    3004209178-2011-06536
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 22, 2011
    Report Date
    October 13, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS WAS COMPLETED AND REVEALED MOTOR FEEDTHRU SHORTED TO CASE-BRIDGING RESIDUE. THE MOTOR 2 FEEDTHRU MEASURED 0.1 OHMS LESS ON HIMP TEST AFTER LEAD WAS CLIPPED. FURTHER INVESTIGATION SHOWED THAT THE MOTOR 2 GLASS INSULATOR HAD BRIDGING ACROSS OF IT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE MEDICATION ADMINISTERED TO THE PATIENT VIA THE PUMP WAS (1) MORPHINE 15.0 MG/ML CONCENTRATION AT A DAILY DOSE OF 0.091 MG/DAY; AND (2) BUPIVICAINE 15.0 MG/ML CONCENTRATION AT A DAILY DOSE OF 0.091 MG/DAY.

    Description of Event or Problem · 1

    A CRITICAL ALARM, CONFIRMED BY TELEMETRY, DUE TO A MOTOR STALL WAS REPORTED. THE STALL WAS CONSTANT. IT WAS STATED THAT THE PUMP HAD BEEN ALARMING INTERMITTENTLY SINCE (B)(6) 2011. THE ALARM TONES WERE DESCRIBED AS "THE SOUND OF A FOREIGN POLICE CAR" AND ALSO "TWO TONED." ON INTERROGATION, A TOTAL OF 5 INTERMITTENT STALLS AND RECOVERIES WERE NOTED SINCE (B)(6) 2011, THE LAST STALL BEING ON (B)(6) 2011 WITH NO RECOVERY. CAUSE OF THE STALL WAS UNK. THE PUMP WAS SET IN MINIMUM RATE INFUSION MODE PROGRAMMING AND PT WAS PRESCRIBED OTHER MEDICATIONS. PT EXPERIENCED WITHDRAWAL SYMPTOMS OF ABDOMINAL CRAMPS, DIARRHEA AND INCREASED PAIN ON (B)(6) 2011. THE DRUGS DELIVERED VIA THE PUMP WERE MORPHINE AND BUPIVACAINE. IT WAS LATER REPORTED THAT THE PUMP WAS REPLACED AND PT RECOVERED WITHOUT ANY SEQUELAE. AS OF (B)(6) 2011, PT WAS REPORTED AS "DOING WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention (B)(4)| CATHETER: MODEL 8709, LOT# N100896012| IMPLANTED:| EXPLANTED: