BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2821495 · Received November 6, 2012

    Report

    Report Number
    3004209178-2012-09961
    Event Type
    Injury
    Date Received
    November 6, 2012
    Report Date
    October 9, 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
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709SC SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER: PRODUCT ID, 8590-9 LOT# N331039, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED INCREASED BASELINE PAIN. DESPITE DOSING INCREASES THE PAIN SYMPTOMS PERSISTED. A VOLUME DISCREPANCY WAS NOTED. THE ACTUAL RESIDUAL VOLUME (ARV) OF 20ML WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME (ERV) OF 13ML. HCP BELIEVED THERE WAS A KINK TO THE CATHETER VIA X-RAY. THE SURGEON WANTED HCP TO RULE OUT THE PUMP AND DO A ROLLER STUDY. THERE WAS NOTHING ABNORMAL NOTED IN THE LOGS. THE RESERVOIR SAID THERE WAS 13.9ML IN THE RESERVOIR BUT THEY BROUGHT THE PATIENT IN FOR A REFILL BECAUSE THEY WERE GOING TO CHANGE THE DOSE AND CONCENTRATION. THE PUMP WAS FILLED WITH SALINE. HCP REPORTED THE CATHETER WAS KINKED. A MYELOGRAM WAS INCONCLUSIVE BUT THEY WERE UNABLE TO ASPIRATE OR BOLUS THE CATHETER. A CATHETER REVISION WAS DONE. THEY UNKINKED THE CATHETER, ASPIRATED IT AND RECEIVED GOOD CEREBROSPINAL FLUID FLOW. THE PUMP WAS DELIVERING FENTANYL, CLONIDINE AND BACLOFEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention