BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3101888 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-04431
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 4, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER; PRODUCT ID 8 709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT COMPLAINED OF INTERMITTENT EFFICACY OF THE MEDICATION, INTERMITTENT PAIN RELIEF, SOMETIMES FELT DRUGGED AND ¿THOUGHT THE PUMP WAS WORKING SPORADICALLY¿. THE CAUSE OF THE EVENT WAS ¿PATIENT REPORTED¿. A CATHETER DYE STUDY WAS PERFORMED ON (B)(6) 2012 AND THE RESULTS WERE NEGATIVE. NO SURGICAL INTERVENTION OCCURRED. THE HEALTH CARE PROVIDER WEANED THE PATIENT OFF DILAUDID AND THE PATIENT¿S SYMPTOMS WERE ¿GONE¿. THE OUTCOME TO THE PATIENT WAS NO INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY HCP PATIENT HAD A CHANGE IN THERAPY EFFECT. INTERMITTENT OVERDOSE/WITHDRAWAL SYMPTOMS WERE REPORTED ALONG WITH INCREASED BASELINE PAIN, NAUSEA AND SOMNOLENCE. PATIENT COULD NOT BE ROUSED FROM SLEEP. AT OTHER TIMES PATIENT WAS SHAKING. HCP NOTED THAT PATIENT REPORTED THERE WAS NO CONSISTENCY AS TO WHEN SYMPTOMS OCCURRED. HCP INDICATED PATIENT THOUGHT IT WAS A CATHETER PROBLEM. HCP THOUGHT CATHETER WAS LEAKING AND HAD SNAPPED BECAUSE THEY WERE FINDING A COLLECTION OF FLUID LUMBAR-WISE AND STATED, ¿IT WAS DEFINITELY FLUID RIGHT WHERE THE CATHETER TURNS, RIGHT WHERE THE ANCHOR WAS. I ENDED UP PUTTING HER ON MINIMUM AND PUTTING HER ON PO MEDS¿. PATIENT TOOK PO DILAUDID FOR BREAKTHROUGH PAIN. PATIENT WAS AT HOME. NO PUMP ALARMS REPORTED. PUMP VOLUMES CHECKED; VOLUMES MEASURED EQUALLY. THE ERV AND ARV MEASURED CALLER REPORTED NO VOLUME DISCREPANCY AT REFILLS. NO DIAGNOSTIC STUDIES PERFORMED. HCP STATED PATIENT SCHEDULED TO FOR A DYE STUDY. LATER ON ((B)(6) 2012) ANOTHER REPORT FOR HCP INDICATED THAT THE PATIENT EXPERIENCED INTERMITTENT OVERDOSE/WITHDRAWAL SYMPTOMS FOLLOWING A REFILL. PATIENT WAS RECEIVING PRIALT AND DILAUDID INTRATHECALLY SINCE 2008 FOR COMPLEX REGIONAL PAIN SYNDROME. ALTHOUGH THE NURSE DENIED INCIDENCE OF OVERDOSE, THE PATIENT BEGAN TO EXPERIENCE INTERMITTENT EPISODES IN WHICH SHE COULD NOT BE AROUSED FROM HER BED WHILE SHE WAS ABLE TO HEAR DURING THAT TIME. THE EPISODES COULD LAST FOR UP TO THREE DAYS. THE NURSE STATED THAT THE EVENT MAY BE RELATED TO A BATTERY PROBLEM, CATHETER PROBLEM OR A DELIVERY ISSUE. AT THE TIME OF THIS REPORT, THE EVENT WAS NOT RESOLVED. SYSTEM USED TO DELIVER DILAUDID AND PRIALT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202567 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Other