BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4306183 · Received December 8, 2014

    Report

    Report Number
    3004209178-2014-22805
    Event Type
    Injury
    Date Received
    December 8, 2014
    Report Date
    November 16, 2014
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AN ALARM WAS HEARD WITH TELEMETRY NOT YET PERFORMED. THE PATIENT WAS AT THE HOSPITAL DUE TO HEARING THE CRITICAL ALARM. THE PATIENT WAS A QUADRIPLEGIC WHO WAS NON-VERBAL AND WAS NOT EXHIBITING ANY CHANGE IN SYMPTOMS. THE NEXT DAY IT WAS REPORTED THAT AFTER INTERROGATING THE PUMP, THE LOGS INDICATED THAT SAFE STATE, RESET, AND RESET-LOW BATTERY ALARMS HAD OCCURRED. THE MESSAGE ¿RESET OCCURRED ¿ LOW BATTERY¿ OCCURRED PRIOR TO THE SAFE RATE. THE SAFE RATE DID NOT OCCUR WHILE UPDATING THE PUMP. THE DOSE WAS IN MINIMUM RATE AT THE TIME OF INTERROGATION. NO ELECTROMAGNETIC INTERFERENCE (EMI) WAS ASSOCIATED WITH THE EVENT. THE PATIENT WAS GIVEN ENTERAL BACLOFEN. THE PATIENT BEGAN TO GET AGITATED AROUND 6AM ON (B)(6) 2014. LATER THAT DAY IT WAS REPORTED THE PATIENT WAS TAKEN TO THE OPERATING ROOM DUE TO THE RESET TO SAFE STATE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS STABLE AT THAT TIME. THE SYSTEM WAS BEING USED TO DELIVER BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789477 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention