BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3844036 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09989
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 12, 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
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8590-1, LOT# N157233, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CRITICAL PUMP ALARM OCCURRED. IT WAS NOTED THAT THE PATIENT¿S SPOUSE TOLD THE HEALTHCARE PROVIDER (HCP) THAT THE PUMP WAS BEEPING EVERY 10 MINUTES. IT WAS REPORTED THAT THE PATIENT HAD INCREASED SPASTICITY. IT WAS NOTED THAT THE PATIENT WAS NOT CURRENTLY IN HOSPITAL OR RECEIVED ANY MEDICAL TREATMENT, PATIENT¿S FAMILY CALLED HCP TO REVIEW SITUATION AND DISCUSS OPTIONS. IT WAS REPORTED THAT THE PUMP WAS USED TO INFUSE BACLOFEN. IT WAS REPORTED TWO DAYS LATER THAT THERE WAS A PUMP PROBLEM. IT WAS NOTED THAT THERE WAS A CONFIRMED MOTOR STALL AND MOTOR STALL RECOVERY RECORDED IN EVENT LOGS. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) WAS NOTIFIED OVER THE COURSE IF THE LAST COUPLE DAYS. IT WAS NOTED THAT THE PATIENT WAS SEEN IN AN EMERGENCY ROOM (ER) ON (B)(6) 2014 DUE TO ALARMING AND WITHDRAWAL. IT WAS REPORTED THAT THE PATIENT WAS GIVEN ORAL ¿PO¿ BACLOFEN BY THE ER. IT WAS NOTED THAT THE PATIENT WENT TO A HOSPITAL ON (B)(6) 2014 FOR EVALUATION AND CHECKED PUMP LOGS. IT WAS REPORTED THAT A MOTOR STALL OCCURRED (B)(6) 2014 AT 23:43 AND TUBE SET OCCURRED (B)(6) 2014 AT 23:43. IT WAS NOTED THAT A MOTOR STALL RECOVERY OCCURRED (B)(6) 2014 AT 05:06. IT WAS REPORTED THAT NO EMI OR MAGNETIC INTERACTION WAS SUSPECTED. IT WAS NOTED THAT THE PATIENT WAS DOING BETTER AT THE TIME OF REPORT. IT WAS REPORTED THAT THE PATIENT WOULD BE MONITORED IN THE HOSPITAL AND PLANS ARE TO REPLACE THE PUMP AT THE TIME OF REPORT. IT WAS NOTED THAT THE PUMP WAS USED TO INFUSE GABLOFEN. IT WAS LATER REPORTED THAT AT FIRST THE PATIENT DID NOT HEAR THE ALARM OR THEY WEREN¿T SURE WHAT IT WAS. IT WAS NOTED THAT MOTOR STALL WAS NOTED IN EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. IT WAS REPORTED THAT THE MOTOR STALL WAS CONFIRMED BY A HEALTHCARE PROVIDER (HCP) IN OREGON. IT WAS NOTED THAT THE HCP HOPED TO SEE THE PATIENT LATER ON THE DAY OF REPORT WAS WOULD READ PUMP LOGS. IT WAS REPORTED THAT THE PATIENT FELT ¿TWITCHY¿ AND WAS ITCHING. IT WAS NOTED THAT THE PATIENT WAS GIVEN ORAL BACLOFEN SOMETIME OVER THE WEEKEND AND WAS DOING BETTER AT THE TIME OF REPORT. IT WAS REPORTED THAT THE PUMP WAS MOST RECENTLY REFILLED APRIL 22 AND EXPECTED RESIDUAL VOLUME ERV WAS 3.5 ML AND THE ACTUAL RESIDUAL VOLUME (ARV) WAS 5.1 ML. IT WAS NOTED THAT THE PATIENT WAS SWITCHED TO GABLOFEN IN THE ¿FALL¿ AND WITH GABLOFEN THE SYRINGES THEY GIVE ARE OVERFILLED WITHOUT DEMARCATION WHICH THE HCP BELIEVED COULD LEAD TO OVER FILLING AND THEN VOLUME DISCREPANCIES. IT WAS REPORTED THAT THE PATIENT¿S PUMP WAS USED TO INFUSE GABLOFEN. IT WAS REPORTED THAT BASED ON THE LOGS THE PUMP RESTARTED ON (B)(6) 2014 AND WAS CURRENTLY RUNNING AT THE TIME OF REPORT. IT WAS NOTED THAT THE PUMP WAS USED TO INFUSE LIORESAL. IT WAS LATER REPORTED THAT THE PATIENT HAD SYMPTOMS OF BEING VERY SLEEPING. IT WAS NOTED THAT THE CAUSE OF THE STALL WAS UNKNOWN. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE AN MRI. IT WAS NOTED THAT THE PUMP WAS REPLACED ON (B)(6) 2014. IT WAS REPORTED THAT LIORESAL WAS THE DRUG LISTED IN THE PROGRAMMER THAT THE HEALTHCARE PROVIDER SUPPLIED TO THE MANUFACTURER¿S REPRESENTATIVE. IT WAS NOTED THAT THE MANUFACTURER¿S REPRESENTATIVE COULD NOT VERIFY THE ACCURACY OF THE ACTUAL AGENT. IT WAS REPORTED THAT THE PATIENT¿S PUMP WAS SUCCESSFULLY REPLACED AND FILLED WITH GABLOFEN. IT WAS LATER CLARIFIED THE MEDICATION USED WAS GABLOFEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER INDICATED THAT A THORACOLUMBAR X-RAY WAS NORMAL. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322131 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention