BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3920257 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-12684
    Event Type
    Injury
    Date Received
    July 8, 2014
    Report Date
    June 17, 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
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR STALL OCCURRED AND RECOVERED AFTER MORE THAN 2 HOURS. THE ACTIONS REQUIRED AS A RESULT OF THE EVENT INCLUDED REPLACEMENT. DIAGNOSTIC TESTING OR TROUBLESHOOTING INCLUDED CHECKING THE PATIENT¿S PUMP LOGS. THE PUMP WAS USED TO INFUSE AN UNKNOWN DRUG. THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS ALIVE ¿ NO INJURY. THE PATIENT SYMPTOMS WERE UNKNOWN. IT WAS LATER REPORTED THAT THE PATIENT HAD WITHDRAWAL SYMPTOMS AND INCLUDED NUMBNESS IN FEET, SWEATS AND NAUSEA. ACCORDING TO THE PUMP LOGS, A MOTOR STALL OCCURRED ON (B)(6) 2014 AND RECOVERED ON (B)(6) 2014. ANOTHER MOTOR STALL OCCURRED (B)(6) 2014 AT 02:04 WITH A STOPPED PUMP PERIOD MAY EXCEED TUBE SET ON (B)(6) 2014 AT 02:04, FOLLOWED BY A MOTOR STALL RECOVERY ON (B)(6) 2014 AT 23:08. THE PUMP WAS REPLACED ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. IT WAS NOTED THAT THE PUMP WAS USED TO INFUSE FENTANYL AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD SEVERE PAIN IN THEIR LEGS. THE PATIENT¿S PRINTOUT ON (B)(6) 2014 NOTED A RECOVERY OCCURRED FOR A SHORT TIME; IT WAS UNKNOWN HOW LONG THE PUMP WAS STALLED FOR. IT WAS REPORTED THAT THERE WAS MORE THAN 1 MOTOR STALL NOTED IN THE EVENT LOGS. THE CAUSE OF THE MOTOR STALL WAS UNKNOWN. THE PUMP WAS RE-READ IN A SERIES OF 3 DAYS AND WAS DECREASED TO MINIMUM RATE, 7.4 MCG/DAY, DUE TO THE PUMP RESTARTING THEN STALLING. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397281 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention