BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4000053 · Received August 11, 2014

    Report

    Report Number
    3004209178-2014-15137
    Event Type
    Injury
    Date Received
    August 11, 2014
    Report Date
    July 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPY AND THEY WERE SUSPECTING A CATHETER KINK. THE MANUFACTURER¿S REPRESENTATIVE WAS IN THE MIDDLE OF THE CASE. THE PUMP WAS USED TO INFUSE HYDROMORPHONE AND BUPIVACAINE AT THE TIME OF THE EVENT. IT WAS REPORTED THAT THE PATIENT¿S CATHETER WAS REPLACED DUE TO A LOSS OF THERAPY. IT WAS REPORTED THAT THE PATIENT¿S DOSE WAS (HYDROMORPHONE .4999 MG/DAY AND BUPIVACAINE 14.996 MG/DAY). IT WAS UNKNOWN IF THE PATIENT WAS TAKING ANY ORAL MEDICATIONS. IT WAS REPORTED TWO DAY LATER THAT THE PATIENT¿S PAIN HAD RETURNED SO THE PATIENT¿S HEALTH CARE PROFESSIONAL (HCP) ATTEMPTED A DYE STUDY. THE HCP COULD NOT ASPIRATE OR CONDUCT THE DYE STUDY, SO THE HCP SCHEDULED THE REVISION. IT WAS LATER REPORTED THAT THE HEALTH CARE PROFESSIONAL COULD NOT ASPIRATE THE CATHETER. THE PATIENT REPORTEDLY APPEARED TO BE DOING WELL AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475029 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention