BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3252393 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12422
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 30, 2013
    Report Date
    July 1, 2013
    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
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4). 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

    FINAL ANALYSIS OF THE PUMP FOUND CORROSION, RESIDUE, AND MOISTURE THROUGHOUT THE GEAR-TRAIN. ADDITIONALLY, IT WAS NOTED THAT THE STALL HAD BEEN DUE TO SHAFT-BEARING. H6: CONCLUSION CODE 92 NO LONGER APPLIES.

    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 THAT THE PUMP BEGAN ALARMING. THE REPORTER INITIALLY THOUGHT THAT THE ALARM WAS COMING FROM A DOG COLLAR. UPON INTERROGATION, IT WAS FOUND THAT THE PUMP MOTOR HAD STALLED AND THERE WAS NO STALL RECOVERY NOTED. THERE WAS NO MAGNETIC OR ELECTROMAGNETIC INTERFERENCE NOTED IN RELATION TO THE EVENT. IT WAS STATED THAT THE PATIENT WAS HAVING WITHDRAWAL AND A PUMP REPLACEMENT WAS BEING COORDINATED. AT THE TIME OF REPORT, THERE WERE STILL 18 MONTHS LEFT UNTIL THE ELECTIVE REPLACEMENT INDICATOR WOULD ACTIVATE. ON THE NEXT DAY, IT WAS REPORTED THAT THE PATIENT HAD HEARD THE PUMP ALARM AT NOON AND STARTED TO ¿FEEL FUNNY¿ THAT AFTERNOON. THE PATIENT BEGAN TO EXPERIENCE WITHDRAWAL SYMPTOMS AND HAD TO TAKE ORAL MEDICATIONS. IT WAS FOUND THAT THE PUMP HAD STALLED AND NEVER RECOVERED. THE PUMP WAS SET TO MINIMUM RATE BEFORE BEING EXPLANTED. WITH THE REPLACEMENT PUMP, THE PATIENT¿S DOSE WAS STARTED AT A LOWER RATE AND WOULD BE INCREASED BACK TO THE ORIGINAL DOSE WHEN HE RETURNED FOR HIS POST-OPERATIVE APPOINTMENT TO HAVE STAPLES REMOVED. IT WAS NOTED THAT THE PATIENT WAS DOING GREAT AT THE TIME OF REPORT. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID AND BUPIVACAINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT HAD PRESENTED WITH ¿SEVERE WITHDRAWAL SYMPTOMS¿ OVER 24 HOURS. IT WAS INDICATED THAT THE PUMP HAD BEEN REPLACED WITHIN A 24-HOUR PERIOD OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353762 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention