BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2963071 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02690
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 17, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-3043-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8840. PRODUCT TYPE: PROGRAMMER, PHYSICIAN: PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: CATHETER. (B)(4). FINAL ANALYSIS OF THE PUMP FOUND THAT THE BATTERY HAD HIGH RESISTANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BACLOFEN UNDERDOSE. THE PATIENT HAD PRESENTED WITH A LOW-GRADE TEMPERATURE AND SEVERE SPASMS. AT THE EMERGENCY ROOM, THE PUMP WAS INTERROGATED AND WAS FOUND TO BE RUNNING AT MINIMUM RATE MODE. NOTHING WAS FOUND IN THE PUMP LOGS BESIDES THE MESSAGE "MINIMAL INFUSION MODE, PUMP RESET", WHICH DISAPPEARED AFTER REPROGRAMMING. IT WAS STATED THAT NO ONE HAD TOUCHED THE PUMP AND THE PATIENT HAD NOT BEEN NEAR ANY MAGNETS. IT WAS ALSO NOTED THAT THE PUMP WAS REPROGRAMMED BACK TO THE INITIAL SETTINGS. TWO DAYS LATER, IT WAS REPORTED THAT THE PATIENT HAD BEEN DISCHARGED, BUT SOON RETURNED TO THE EMERGENCY ROOM. THIS TIME THE PATIENT PRESENTED WITH WITHDRAWAL CHARACTERIZED BY INCREASED SPASTICITY, TACHYCARDIA, SWEATING, AND EXCESS SALIVA. AN ALARM WAS OCCURRING AND UPON INTERROGATION IT WAS FOUND THAT THE PUMP WAS IN SAFE STATE DUE TO A LOW BATTERY RESET. TWELVE DAYS AFTER THAT, IT WAS REPORTED THAT THE PUMP HAD BEEN REPLACED DUE TO BATTERY DEPLETION, BUT HAD RECOVERED WITHOUT SEQUELA. THE DRUG USED IN THE SYSTEM WAS GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67906 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R