BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4003603 · Received August 12, 2014

    Report

    Report Number
    3004209178-2014-15179
    Event Type
    Injury
    Date Received
    August 12, 2014
    Report Date
    July 22, 2014
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: CATHETER. PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO ANOMALY. ANALYSIS OF THE 8709 CATHETER REVEALED ACCEPTABLE TESTING AND THE CATHETER WAS INCOMPLETE AND RETURNED IN SEGMENTS. ANALYSIS OF THE UNKNOWN CATHETER/SC CONNECTOR FOUND CORING/TEAR AND CUTS IN THE SEAL. THERE WAS NO LEAK SEEN IN THE LAB AND NO LEAK ALLEGATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP HAD BEEN ¿ACTING FUNKY¿ THE LAST TWO MONTHS. THE PATIENT HAD A NORMAL ¿CSD¿ ON (B)(6) AND THE PUMP WAS AT THE ELECTIVE REPLACEMENT INDICATOR (ERI). REPLACEMENT TOOK PLACE AND THE PATIENT WAS FEELING OVER-/UNDER-DOSING INTERMITTENTLY. SOME DAYS THE PATIENT WAS DROWSY AND SOME DAYS THERE WAS INCREASED PAIN. THE PATIENT HAD OVERDOSE SYMPTOMS AND ¿WOULD FEEL HIGH.¿ THE PATIENT ALSO HAD CHRONIC LOW BACK PAIN. THIS STARTED TWO MONTHS AGO. THE PUMP WAS EXPLANTED AND REPLACED. THERE WAS A CATHETER ISSUE WHICH REQUIRED PARTIAL EXPLANT. THERE WAS SOME ¿CHALKY LOOK¿ IN THE PUMP POCKET AND THE PHYSICIAN RECOMMENDED REPLACING THE CATHETER PUMP SEGMENT AND RETURNING IT FOR ANALYSIS. THE CATHETER WAS TRIMMED 8.5 CENTIMETERS AND A NEW CATHETER SEGMENT WAS ADDED WITH CEREBROSPINAL FLUID (CSF) FLOW FROM THE CATHETER. A DYE STUDY AND X-RAYS WERE DONE AND THE LOGS WERE CHECKED. AN MRI WAS DONE ON JULY 18 (DURING WHICH TIME A MOTOR STALL AND MOTOR STALL RECOVERY WERE SEEN WITH A 47 MINUTE STALL DURATION). THE CATHETER PRODUCT ISSUE WAS RESOLVED. THE SYSTEM WAS BEING USED TO DELIVER MORPHINE AND FENTANYL. ON (B)(6) 2014 THE MORPHINE DOSE WAS DECREASED TO 9.990 MILLIGRAMS PER DAY FROM 13.043 MILLIGRAMS PER DAY. THE FENTANYL DOSE WAS DECREASED FROM 250.82 MICROGRAMS PER DAY TO 192.11 MICROGRAMS PER DAY. IT WAS LATER REPORTED THE CATHETER DYE STUDY AND X-RAY RESULTS WERE ALL NORMAL. THE PATIENT WAS PRESCRIBED 15 MILLIGRAM (MG) TABLETS OF MORPHINE AND 5 MG TABLETS OXYCODONE, BOTH TAKEN AS NEEDED. THE ACTUAL FREQUENCY IN WHICH THE PATIENT TOOK THEM WAS UNKNOWN. THE REASON FOR THE ISSUES THAT THE PATIENT EXPERIENCED WAS NOT KNOWN. THE PATIENT WAS BEING MONITORED. IT WAS NOT KNOWN HOW THE PATIENT WAS DOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478510 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention