BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3191432 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10936
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 2, 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
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED A PUMP/MOTOR/GEAR TRAIN ANOMALY/CORROSION AND-OR WEAR AND-OR LUBRICATION. ALSO A PUMP/MOTOR/GEAR TRAIN ANOMALY/STALL DUE TO SHAFT-BEARING.

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8709 SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: UNK. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP ALARM OCCURRED, AND UPON INTERROGATION A PUMP MOTOR STALL WAS CONFIRMED TO HAVE OCCURRED ON (B)(6) 2013 (TEN HOURS PREVIOUS TO THE PHONE CALL). AT THE TIME OF THE PHYSICIAN¿S PHONE CALL ON (B)(6) 2013, THE PATIENT HAD CLEARLY EXPERIENCED SIGNS OF UNDERDOSE OVER THE PAST THREE HOURS. THE PATIENT WAS GOING TO BE ADMITTED TO THE HOSPITAL AND NEUROSURGERY HAD BEEN CALLED FOR URGENT REPLACEMENT SURGERY. THE PUMP DOSE WAS PLANNED TO BE REDUCED AND THE PATIENT WAS BEING ¿COVERED¿ PER THE PHYSICIAN. DRUG DELIVERED VIA THE DEVICE WAS LIORESAL. FOLLOW-UP INFORMATION RECEIVED LATER NOTED THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM IN WITHDRAWAL. HE PRESENTED WITH INCREASED SPASTICITY AND UNDERDOSE SYMPTOMS OF ITCHING AND TWITCHING AT THE DEVICE POCKET, AND HE WAS AGITATED. PATIENT UNDERWENT A PUMP EXPLANT PROCEDURE ON (B)(6) 2013, DURING WHICH HIS PUMP WAS REPLACED AS IT WAS DETERMINED THAT THE PUMP WAS NOT WORKING. A PUMP TELEMETRY REPORT TAKEN ON (B)(6) 2013, SHOWED THAT A PUMP MOTOR STALL OCCURRED ON (B)(6) 2013 AT 16:26.10 AND NEVER RECOVERED. THE PATIENT WAS GIVEN AN ADDITIONAL BOLUS OF 327 MCG (NOT A PRIMING BOLUS) DURING SURGERY WHEN THE SURGEON FLUSHED THE CATHETER WITH SALINE. FOLLOWING THE SURGERY, THE PATIENT HAD A DIFFICULT TIME WAKING UP FROM THE ANESTHESIA. THE PATIENT WAS DISCHARGED HOME AND WAS DOING FINE AS OF THE DATE OF THE REPORT. IT WAS LATER REPORTED THAT THE MOTOR HAD STALLED FOR OVER FOUR DAYS, CAUSE UNKNOWN. PATIENT EXPERIENCED MYOCLONUS, INCREASED TONE, IRRITABILITY. ON (B)(6) 2013, THE PATIENT HAD A BOLUS WITH NO EFFECT. PATIENT OUTCOME WAS INDICATED AS SERIOUS WITH WITHDRAWAL. PATIENT RECOVERED WITHOUT SEQUELA FOLLOWING PUMP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289990 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00009 YR Hospitalization| O| R