BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3071533 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06689
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    March 25, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED OVERINFUSION- UNDETERMINED ROOT CAUSE. ANALYSIS OF THE CATHETER REVEALED NO SIGNIFICANT ANOMALY, MISCELLANEOUS TESTING CATHETER INCOMPLETE RETURNED IN SEGMENTS.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE EVENT WAS DUE TO A POSSIBLE PUMP MALFUNCTION. THE PUMP WAS SURGICALLY REPLACED ON (B)(6) 2013. THE P ATIENT RECOVERED WITHOUT SEQUELAE ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS WITH POSSIBLE OVER/UNDER INFUSION WITH A VOLUME DISCREPANCY OF 2.2ML ON (B)(6) 2012 AND OF 3.6ML ON (B)(6) 2013. THE PATIENT HAD SYMPTOMS OF NAUSEA, VOMITING, EXCESSIVE SWEATING, AND INCREASED PAIN. THE SEVERITY OF THE EVENT WAS REPORTED AS MILD. THE PUMP WAS USED TO DELIVER DILAUDID, BUPIVACAINE AND BACLOFEN. IT WAS LATER REPORTED THAT THE PATIENT'S PUMP WAS OVER-INFUSING AND CAUSING AN OVERDOSE OF THE PATIENT. THE HEALTHCARE PROVIDER (HCP) SAW THE PATIENT IN THE CLINIC ON (B)(6) 2013 AND PERFORMED A REFILL. FOLLOWING THE REFILL, THE PATIENT WENT TO THE HOSPITAL AND IT WAS INITIALLY THOUGHT THE PATIENT WAS "WITHDRAWING." THE HCP THEN BELIEVED THE SYMPTOMS WERE OVERDOSE RELATED, RATHER THAN WITHDRAWAL RELATED AND DECIDED TO CHECK PATIENT'S PUMP VOLUMES 2 WEEKS FROM THE DATE OF REPORT. THERE WERE VOLUME DISCREPANCIES LEADING UP TO THE EVENT OF; 1.99ML ON (B)(6) 2012, 2.2ML ON (B)(6) 2012 AND 3.6ML ON (B)(6) 2013. ALL OF THE DISCREPANCIES WERE INSTANCES OF OVER-INFUSION AND HAD THE HCP "VERY CONCERNED." IN ADDITION TO THE VOLUME DISCREPANCY, THE PATIENT WAS EXHIBITING SOME LEVEL OF "DOPINESS" AFTER THE REFILL, CONSISTENT WITH OVERDOSE. THEN, THE OVERDOSE SYMPTOMS SUBSIDE AT SOME POINT AND THE PATIENT APPEARED TO HAVE NORMAL THERAPEUTIC COVERAGE. THE PATIENT THEN PRESENTS WITH A LOSS OF EFFECTIVENESS PRIOR TO THE SCHEDULED REFILL DATE, CONSISTENT WITH UNDER-DOSING OR EVEN SYMPTOMS OF WITHDRAWAL. IT WAS LATER REPORTED THAT IT WAS NOT KNOWN BY THE REPORTER HOW THE PATIENT WAS DOING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT A VOLUME DISCREPANCY OF 2.4ML WAS OBSERVED DURING A REFILL ON (B)(6) 2013. IT WAS NOTED THAT DURING A REFILL THE INTERROGATED RESERVOIR VOLUME WAS 2.2ML AND THERE WERE 0ML REMAINING IN THE RESERVOIR. THE PATIENT RECOVERED WITHOUT SEQUELAE AS OF (B)(6) 2013. IT WAS LATER REPORTED THAT SEVERAL VOLUME DISCREPANCIES WERE OBSERVED DURING REFILLS RANGING FROM THE DATE OF IMPLANT, (B)(6) 2009 TO (B)(6) 2013. ALL VOLUME DISCREPANCIES WERE WITHIN SPECIFICATION EXCEPT FOR A REFILL ON (B)(6) 2009 AT WHICH TIME THE EXPECTED RESIDUAL VOLUME (ERV) WAS 24.3ML AND THE ACTUAL RESIDUAL VOLUME (ARV) WAS 0.3ML; A DIFFERENCE OF 24ML. SEVERAL DOSE ADJUSTMENTS WERE MADE DURING THIS TIME SPAN AS WELL. PER THE PUMP LOGS, BACLOFEN WAS ADDED TO THE PUMP ON (B)(6) 2010. IT WAS LATER REPORTED THAT THE VOLUME DISCREPANCIES REPORTED ON (B)(6) 2012 AND (B)(6) 2013 WERE ALL INSTANCES OF OVERINFUSION. THE OVERINFUSION CAUSED THE EARLY EMPTY RESERVOIR, AND THEREFORE RESULTED IN UNDERINFUSION, AS IT WAS EXPECTED THE PUMP WAS DELIVERING MEDICATION. IT WAS LATER REPORTED THAT THE DOCTOR VERIFIED THAT THE PATIENT WAS NOT EXPERIENCING SYMPTOMS OF OVERINFUSION OR UNDERINFUSION. THE 2.4ML DISCREPANCY DID NOT ALARM THE DOCTOR AS IT WAS NOT ACCOMPANIED WITH OTHER SYMPTOMS. THE OUTCOME WAS REPORTED AS ONGOING WITH NO FURTHER ACTION NEEDED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENT WITHDRAWAL SYMPTOMS. THE PATIENT HAD INTERMITTENT RELIEF FROM SYMPTOMS. A VOLUME DISCREPANCY AGAIN OCCURRED DURING A PUMP REFILL ON (B)(6) 2013 WHERE THE ERV WAS 22.5ML AND THE ARV WAS 20ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171083 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Other| R