BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2525278 · Received April 10, 2012

    Report

    Report Number
    3004209178-2012-02247
    Event Type
    Injury
    Date Received
    April 10, 2012
    Date of Event
    March 19, 2012
    Report Date
    March 19, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6); POUCH: MODEL: 8590-1, LOT# N151979, IMPLANTED: 2008 (B)(6), EXPLANTED: UNK; CATHETER: MODEL: 8578, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: UNK. (B)(4). ANALYSIS RESULTS OF THE RETURNED 8709SC CATHETER WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE PARTIAL CATHETER RETURNED REVEALED NO SIGNIFICANT ANOMALY; ACCEPTABLE TESTING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED THAT A DYE STUDY WAS DONE ON (B)(6) 2012. IT REVEALED THAT EXTRAVASATION OF DYE ALONG THE LENGTH OF THE CATHETER AROUND THE PUMP. THREE SEPARATE SITES OF LEAK WERE IDENTIFIED. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED AN INCREASE IN TRUNK PAIN, RIGHT LOWER EXTREMITY NUMBNESS AND DIZZINESS. THE PUMP CONTAINED MORPHINE 22MG/ML, 12MG/DAY, BUPIVACAINE 10MG/ML, 5.5MG/DAY, CLONIDINE 400MCG/ML, 220MCG/DAY, AND BACLOFEN 100MCG/ML, 55MCG/DAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY AS THE HEALTHCARE PROVIDER (HCP) WAS TUNNELING AND CONNECTING THE SC (SUTURELESS CONNECTOR) TO THE CUT END OF THE CATHETER, HE ACCIDENTALLY PUT THE STRAIN RELIEF SLEEVE ON IN THE WRONG DIRECTION; UPON TRYING TO PULL THE PIN BACK OUT OF THE CUT END OF THE CATHETER THE PIN PULLED OUT OF THE SC PIECE. AT THIS POINT THE HCP ELECTED TO UTILIZE A NEW SC AS HE DID NOT FEEL CONFIDENT IN THE INTEGRITY OF THE CONNECTOR THAT CAME WITH THE CATHETER. PATIENT WAS WITHOUT INJURY; RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PUMP WAS NOT DISPENSING MEDICATION ACCURATELY AND "WAS OFF BY 20 - 30%". THE PATIENT STATED THAT THE HEALTHCARE PROVIDER (HCP) THOUGHT THE CATHETER WAS THE ISSUE AND THEREFORE IT WAS REPLACED, BUT LATER A MOTOR STALL OCCURRED AND THE PUMP HAD TO BE REPLACED (REFER TO MANUFACTURER REPORT #3004209178-2012-03492).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT FELT THE PUMP WAS "ACTING FUNKY" FROM (B)(6) 2011, BUT THE HEALTH CARE PROFESSIONAL DETERMINED IT WAS THE CATHETER. THERE WAS A KINK IN THE CATHETER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS LATER REPORTED THAT AS OF (B)(6) 2011 PATIENT HAD EXPERIENCED EITHER NOT 'GOOD ENOUGH RELIEF' OR HAD EXPERIENCED THE EFFECT OF 'TOO MUCH MEDICATION'. IT WAS NOW INDICATED THAT THE SURGERY (REPORTED IN THE INITIAL REPORT) WAS A CATHETER REVISION. DRUGS DELIVERED VIA THE DEVICE WERE MORPHINE, CLONIDINE, BUPIVACAINE, AND BACLOFEN (UNKNOWN).

    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 00051 YR Required Intervention