BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2874215 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-11862
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# J0039977R, IMPLANTED: (B)(6) 2000. PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS OF THE PUMP NGV408552H REVEALED A PUMP MOTOR FEEDTHRU ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP REPLACEMENT WAS SCHEDULED FOR (B)(6) 2012 DUE TO MOTOR STALL WITH NO MOTOR STALL RECOVERY. TELEMETRY CONFIRMED A CRITICAL ALARM OCCURRED, "RESET OCCURRED - LOW BATTERY" AND "PUMP IN SAFE STATE" OCCURRED ON OR AROUND THE DATE OF (B)(6) AND PERSISTED. THE REPORTER STATED THAT ALL THIRTY LINES STAMPED INTO THE EVENT LOGS WERE FROM THE DAY OF THE REPORT, (B)(6), SO IT WAS HARD TO SAY HOW LONG THE PUMP HAD BEEN ALARMING; HOWEVER, THE PATIENT REPORTED HEARING A BEEPING. THE PATIENT PRESENTED TO THE CLINIC ON THE DAY OF THE REPORT AFTER EXPERIENCING SYMPTOMS OF BACLOFEN WITHDRAWAL. SYMPTOMS INCLUDED INCREASED SPASTICITY, "PRETTY SHAKY" AND HIS ARMS WERE SPASMING. PATIENT OUTCOME WAS NOT PROVIDED. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL (BACLOFEN). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DOSE WAS INCREASED B)(6) 2012 AND THEY APPEARED TO BE RECEIVING EFFECTIVE THERAPY. IT WAS LATER REPORTED THAT THE PUMP WAS REPLACED AND THE PATIENT RECOVERED WITHOUT ANY ISSUE. IT WAS CONFIRMED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY AND THE PUMP WAS DELIVERING GABLOFEN.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R