BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3896883 · Received June 26, 2014

    Report

    Report Number
    3004209178-2014-12085
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    March 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1579-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED THE PUMP MOTOR HAD A FEEDTHRU ANOMALY WITH SHORTING ACROSS THE INSULATOR.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL # UNKNOWN, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014 A LOW BATTERY WARNING HAD APPEARED, HOWEVER, THE ESTIMATED ERI WAS 14 MONTHS. REPORTEDLY, THE PUMP STOPPED ABRUPTLY SEVERAL MONTHS AGO WITH NO APPARENT REASON. THE PUMP INFORMATION REVEALED THAT A PUMP STOPPED PERIOD MAY EXCEED TUBE SET ALSO OCCURRED ON (B)(6) 2014. IT WAS NOT INVESTIGATED SOONER AS THE PATIENT DID NOT WANT A REPLACEMENT PUMP. THE PUMP WAS EXPLANTED DUE TO EARLY BATTERY DEPLETION AND A NEW PUMP WAS NOT IMPLANTED. THE PATIENT¿S STATUS WAS REPORTED AS FULLY RECOVERED. THIS DEVICE SYSTEM DELIVERED CLONIDINE AND ¿NIL.¿ ADDITIONAL INFORMATION WAS REQUESTED. IT WAS FURTHER REPORTED THAT THE PATIENT¿S CATHETER WAS LEFT IN SITU AND SEALED VIA CLIPS. THE DRUG USED WAS CLONIDINE 1,500.0 MCG/ML, THE AMOUNT OF DRUG WITHDRAWN FROM THE PUMP WAS 4.9 ML (THE RESERVOIR VOLUME WAS 5.4ML). THE PATIENT HAD BEEN USING A ¿PA DEVICE¿ WHICH SEEMED TO BE WORKING WELL. FURTHER, THE PUMP WAS NOTED TO BE IN SAFE STATE ON (B)(6) 2014. RESET LOW BATTERY MESSAGES OCCURRED ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS FURTHER PROVIDED THAT THE PATIENT WAS REPORTED TO HAVE NEEDED TO STAY IN THE INTENSIVE CARE UNIT AS HE HAD A SYMPATHETIC STORM AND WAS VERY UNWELL. THE PATIENT WAS NOW COPING "OK" ON SOME ORAL MEDICATIONS. THE DEVICE SYSTEM DELIVERED 100% CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374362 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization| R