BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3142381 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08530
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    July 31, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8596, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER; PRODUCT ID 8598, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE ¿THEORY¿ WAS THAT THE PATIENT WAS SENSITIVE TO LOW VOLUMES IN HER DEVICE AND THE DECISION WAS MADE TO PERFORM REFILLS ONCE THE PATIENT HAD 10ML LEFT IN THE PUMP. THE DYE STUDY AND RADIOLOGY WERE PERFORMED ON (B)(6) 2012 AND NO ABNORMALITIES WERE FOUND. THE PUMP AND CATHETER WERE FUNCTIONING PROPERLY. THERE WERE NO REAL ISSUES EXCEPT BEHAVIOR. THE PATIENT WAS WITHDRAWN AND NOT SMILING. A DOSAGE DECREASE WAS DONE AND THE PATIENT¿S BEHAVIOR IMPROVED. THE HEALTHCARE PROVIDER (HCP) DID DISCUSS NON-PUMP RELATED ISSUES THAT COULD HAVE CAUSED THE BEHAVIOR. A WEEK LATER, THE PATIENT BECAME CRANKY AND WAS BROUGHT BACK TO THE CLINIC. THE PATIENT WAS FOUND TO HAVE A SINUS INFECTION, WAS SEVERELY CONSTIPATED AND HAD KIDNEY STONES. THESE WERE NOT RELATED TO THE DEVICE OR THE MEDICATION IN THE DEVICE. AT A REFILL ON (B)(6) 2012, THE ESTIMATED RESERVOIR VOLUME (ERV) WAS 10.1 AND THE ACTUAL RESERVOIR VOLUME (ARV) WAS 13.0. AT THE TIME OF THE REPORT, A HOME INFUSION SERVICE WAS PERFORMING REFILLS. THE LAST REFILL WAS ON (B)(6) 2013. THE NEXT REFILL WAS TO BE ON (B)(6) 2013. AT THE TIME OF THE REPORT, THERE HAD BEEN NO ISSUES WITH THERAPY OR BEHAVIOR. IT WAS LATER REPORTED THAT AT A REFILL ON (B)(6) 2013, THE ERV WAS 7ML AND THE ARV WAS 4ML. ON (B)(6) 2013, THE ERV WAS 10 AND THE ARV WAS 6.4. IT WAS UNKNOWN IF THERE WAS ALWAYS A 3-4ML DISCREPANCY WITH THIS DEVICE. IT WAS UNKNOWN WHEN VOLUME DISCREPANCIES BEGAN IN RELATION TO THE BEHAVIORAL ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IN THE HOSPITAL. THE PATIENT HAD BEEN HAVING ISSUES WITH THE PUMP SINCE (B)(6) 2012. THE PATIENT EXPERIENCED ¿GOOD DAYS AND BAD DAYS¿ AND SHE WAS ¿ON AND OFF.¿ THE PATIENT WAS USUALLY FINE UNTIL ABOUT 3 PM BUT THEN WOULD BE AGITATED AND SPASTIC FOR 6-7 HOURS AND THEN RELAX AGAIN. ON THE WEEKEND OF (B)(6) 2013 THE PATIENT HAD ¿OFF DAYS,¿ AND SHE WAS AGITATED THE WHOLE DAY. IT WAS ALSO REPORTED THAT AT UNKNOWN TIMES MORE ¿MEDS¿ WERE PULLED OUT OF THE PATIENT¿S PUMP THAN WHAT WERE EXPECTED. A CATHETER DYE STUDY WAS GOING TO BE PERFORMED AT THE HOSPITAL ON (B)(6) 2013. THE PUMP WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EVENT WAS NOT PUMP OR CATHETER RELATED. A CT SCAN PERFORMED (B)(6) 2013 SHOWED NO ABNORMAL EXTRAVASATION AND CATHETER DYE STUDY NO PROBLEMS. THE PATIENT WAS IRRITABLE WITH INCREASED SPASTICITY; HISTORY OF THIS 1-2 DAYS PRIOR TO PUMP REFILL. ALSO SLEEPY AND LOOSER AFTER PUMP REFILLS. IT WAS NOTED THAT THE PATIENT DETERMINED TO HAVE INCREASED SENSITIVITIES TO LOW RESIDUAL VOLUME AT TIME OF PUMP REFILL. OVERALL DAILY DOSAGE DECREASED AND PUMP REFILLS PLANNED WITH SLIGHTLY HIGHER RESERVOIR VOLUMES. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT, AT A REFILL ON (B)(6) 2011, THE EXPECTED RESIDUAL VOLUME (ERV) WAS 6.3ML AND THE ACTUAL RESIDUAL VOLUME (ARV) WAS 7ML. ON (B)(6) 2011, THE ERV WAS 7.3ML, ARV WAS 8ML. ON (B)(6) 2012, THE ERV WAS 4.3ML, ARV WAS 6ML. ON (B)(6) 2012, THEERV 6.2ML, ARV WAS 8ML. ON (B)(6) 2012, ERV WAS 1.8ML, ARV WAS 4ML. ON (B)(6) 2012, ERV WAS 2.5ML, ARV WAS 5ML. ON (B)(6) 2013 WAS 5.6ML, ARV WAS 8.5ML. ON (B)(6) 2013, ERV WAS 2.7ML, ARV WAS 5ML. ON (B)(6) 2013, ERV WAS 4ML, ARV WAS 7ML. ON (B)(6) 2013, ERV WAS 10.1ML, ARVWAS 13ML. ON (B)(6) 2013, ERV WAS 6.4ML, ARV WAS 10ML. IT WAS NOTED THAT THE REFILLS WERE ROUTINELY DONE BY A HOME CARE AGENCY AND BY THE SAME NURSE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE DATA REGARDING VOLUME DISCREPANCIES DID ¿SHOW A TREND¿. THE INITIAL DISCREPANCIES WERE ONLY 0.7ML AND INCREASED TO UPWARDS OF 4ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243281 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization