BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3052483 · Received April 11, 2013

    Report

    Report Number
    3004209178-2013-06000
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    May 24, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2009, A BLOOD TEST WAS ORDERED AND CONFIRMED A DISORDER OF LIVER FUNCTION. A THAT TIME, THE DOCTOR COMMENTED THAT IT WAS NOT PUMP RELATED. THE PATIENT RECOVERED. IT WAS LATER REPORTED THAT A DOSING CHANGE OCCURRED ON (B)(6) 2009, AND THE REASON FOR THE VISIT WAS THE ONSET OF AN ADVERSE EVENT. VOLUME DISCREPANCIES WERE NOTED TO BE IN SPECIFICATION. THE PATIENT'S HEPATIC DYSFUNCTION WAS NOTED TO HAVE ONSET ON (B)(6) 2008, AND IT WAS AGAIN NOTED THAT IT WAS NOT RELATED TO THE DEVICE SYSTEM, BUT WAS POSSIBLY RELATED TO THE INVESTIGATIONAL DRUG. AN EXACERBATION OF RENAL ACTIVITY WAS NOTED TO HAVE ONSET ON (B)(6) 2008, AND THE PATIENT RECOVERED ON (B)(6) 2008. THE CAUSE WAS UNKNOWN, BUT IT WAS NOT THOUGHT TO BE 'PUMP TROUBLE.' THERE WAS NO EXACERBATION OF RENAL ACTIVITY AFTERWARDS. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED AN EXACERBATION OF SPASMS. THE PATIENT WAS ADMITTED DUE TO AN EXACERBATION OF SPASMS ON (B)(6) 2008. A THOROUGH EXAMINATION INVOLVING A CONTRAST EXAMINATION AND ROTOR TEST WAS PERFORMED, AND NO PROBLEMS WITH THE ITB SYSTEM WERE NOTED. A WAIT-AND-SEE APPROACH WAS TO BE TAKEN. IT WAS LATER REPORTED THAT THE PATIENT HAD GOOD PROGRESS FOR ONE TO TWO MONTHS AT THE SAME DOSE, BUT THE EFFECT SUDDENLY DIMINISHED. THIS WAS CONSIDERED TO HAVE CAUSE THE EXACERBATION OF SPASMS. FURTHER INQUIRY REVEALED THE PATIENT'S HEPATIC DYSFUNCTION WAS AN ADVERSE EVENT THAT DEVELOPED DUE TO THE EXACERBATION OF MUSCLE TENSION. THE PATIENT HAD A 'HIGH BODY TEMPERATURE AT 37 C.' NO TREATMENT WAS PERFORMED IN RESPONSE TO THE PATIENT'S HEPATIC DYSFUNCTION, AND IT WAS FURTHER NOTED THAT THERE WAS A POSSIBILITY OF INFECTION, WITH OTHER CONTRIBUTING FACTORS UNKNOWN. IT WAS NOTED THAT THE ADVERSE EVENT WAS NOT A SERIOUS EVENT, RESULTING IN THE WAIT-AND-SEE APPROACH THAT WAS PREVIOUSLY TAKEN. THE PATIENT'S ELEVATED HEART RATE WAS THOUGHT TO BE AN ASSOCIATED SYMPTOMS RESULTING FROM THE EXACERBATION OF MUSCLE TENSION. IT WAS LATER REPORTED THAT THE PATIENT'S PUMP AND CATHETER WERE NOT EXPLANTED OR REPLACED. FOUR REFILLS FROM (B)(6) 2010 THROUGH (B)(6) 2011 INDICATED NO VOLUME DISCREPANCIES THAT WERE OUT OF SPECIFICATION. THE PATIENT'S OUTCOME WAS NOT PROVIDED, BUT NO SYMPTOMS WERE REPORTED. THE MEDICATION USED WITHIN THE SYSTEM WAS GABALON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154488 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00013 YR Other