BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2873876 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-11839
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 16, 2012
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL: UNKNOWN, SERIAL#: UNKNOWN, IMPLANTED: UNKNOWN, EXPLANTED: UNKNOWN, PRODUCT TYPE CATHETER. (B)(4) ("BLOOD PRESSURE OUT OF WACK").

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, EXPLANTED: 2012-(B)(6), PRODUCT TYPE CATHETER. ANALYSIS OF THE CATHETER BODY FOUND A USER RELATED HOLE AND THAT IT HAD BEEN INCORRECTLY ASSEMBLED. DURING PRESSURE TESTING LEAKS WERE SEEN AT THE PROXIMAL END OF SEGMENT 2 AND THE DISTAL END OF SEGMENT 3. THE TECHNICIAN INSPECTED THE SEGMENTS UNDER THE SCOPE AND NOTICED HOLE ON BOTH SEGMENTS. THE APPEARANCE OF THE HOLE ON SEGMENT 2 COULD POSSIBLY BE SHEARING DURING IMPLANT. IT IS ASSUMED THAT THE CATHETER WAS NOT IN THIS CONDITION BEFORE LEAVING MANUFACTURING. THE HOLE WAS SEEN OVER THE BAR OF THE PIN CONNECTOR OF SEGMENT 3. THE HOLE WAS LIKELY DUE TO MATERIAL DEGRADATION AND LONG IMPLANT TIME. THERE WAS A DEFORMED SHAPE ON THE PROXIMAL END WHERE THE CATHETER WAS CONNECTED TO THE PIN CONNECTOR. THERE WAS A SUTURE ATTACHED DIRECTLY ON THE CATHETER BODY (PROXIMAL END) OF SEGMENT 3. THERE WAS NO DISTAL STRAIN RELIEF SLEEVE ATTACHED OR RETURNED. ALSO OF NOTE THE CATHETER WAS DAMAGED. THE APPEARANCE OF THE DAMAGE COULD POSSIBLY BE NEEDLE STICK OR POSSIBLY RELATED TO NO STRAIN RELIEF SLEEVE USE. THE WAS NO LEAK SEEN AT THE DAMAGED LOCATION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT EXPERIENCED WITHDRAWAL DUE TO A BREAK, TEAR, OR HOLE IN THE CATHETER AT THE PROXIMAL PUMP SEGMENT AND DRUG EFFECTS. IT WAS ALSO REPORTED THE ISSUE WITH DRUG EFFECTS WAS A DECREASED RATE. A CATHETER DYE STUDY WAS PERFORMED ON (B)(6) 2012 AND THE CATHETER WAS REPLACED. SIGNS AND SYMPTOMS OF THE EVENT INCLUDED INCREASED DROWSINESS, NAUSEA, DIARRHEA, AND CHILLS. IT WAS ALSO REPORTED THE PATIENT REQUIRED HOSPITALIZATION AND THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    A LACK OF THERAPEUTIC EFFECT AND WITHDRAWAL WAS REPORTED. THE PATIENT STARTED TO NOTICE MORE PAIN 3-4 WEEKS AGO. ON FRIDAY, (B)(6) 2012, HE WENT TO HIS MANAGING PHYSICIAN'S OFFICE AND THE HCP TOOK MEDICATION OUT OF THE PUMP. ON MONDAY, (B)(6) 2012, A DYE STUDY WAS DONE AND THE HCP DETERMINED THERE WERE 3 LEAKS AT THE CATHETER SITE. THE HCP PUT MEDICATION BACK INTO THE PUMP AND SENT THE PATIENT HOME. ON TUESDAY, (B)(6) 2012, THE PATIENT HAD TROUBLE WAKING UP AND HIS BLOOD PRESSURE WAS "OUT OF WACK." THE PHYSICIAN TURNED THE PUMP DOWN. BUT THE PATIENT ENDED UP HAVING AN INFECTION IN HIS BLOOD AND THE HCP DIRECTED THE PATIENT TO SEE HIS FAMILY DOCTOR. THE PATIENT WAS THEN ADMITTED TO THE HOSPITAL WITH SNEEZING, RUNNY NOSE, HIGH FEVER AND NUMBNESS AT THE PUMP SITE. AS OF (B)(6) 2012, THE PATIENT'S FEVER WAS STILL NOT UNDER CONTROL AND HE WAS STILL IN THE HOSPITAL. DRUGS DELIVERED VIA THE DEVICE WERE BACLOFEN AND MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CLARIFIED A LEAK HAD BEEN IDENTIFIED AT THE ANTERIOR CONNECTION SITE. A SUSPECTED BREAK, TEAR, OR HOLE WAS ALSO NOTED. A ROTOR STUDY WAS NOT PERFORMED. THE CATHETER WAS REPLACED. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R