BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4852525 · Received June 18, 2015

    Report

    Report Number
    3004209178-2015-11805
    Event Type
    Injury
    Date Received
    June 18, 2015
    Report Date
    May 30, 2015
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2015 (B)(6), EXPLANTED: 2015 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8835, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD A SPINAL HEADACHE FROM CSF (CEREBROSPINAL FLUID) LOSS AROUND THE SPINAL CATHETER. THE PATIENT ALSO HAD A PUMP POCKET SEROMA. THE PATIENT WAS TAKEN SO SURGERY ON (B)(6) 2015. A PURSE STRING SUTURE WAS APPLIED TO MINIMIZE THE CSF LOSS AND THE ANCHOR WAS RE-SECURED INTO PLACE AS IT WAS NOT IMBEDDED INTO THE FASCIA UP TO THE WINGS. THE CATHETER WAS ASPIRATED AT THE START OF THE SURGERY AND THEN AGAIN AFTER THE PURSE STRING SUTURE WAS APPLIED TO CONFIRM CATHETER PATENCY. THE PUMP POCKET SEROMA WAS DRAINED AND THE POCKET WAS CLOSED. AN ABDOMINAL BINDER WAS PLACED ON THE PATIENT. THE PLAN WAS TO KEEP THE PATIENT FLAT FOR 24 HOURS AFTER THE SURGERY. THE PATIENT STATUS WAS REPORTED AS ¿ALIVE-NO INJURY¿. THE DEVICE SYSTEM WAS DELIVERING DILAUDID AND BUPIVACAINE. ON (B)(6) 2015, IT WAS REPORTED THAT THE CAUSE OF THE FLUID LEAK AROUND THE CATHETER WAS UNKNOWN. THE CSF LEAK WAS DIAGNOSED VIA PATIENT SYMPTOMOLOGY. NO ADDITIONAL INTERVENTIONS OR ACTIONS HAD TAKEN PLACE. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. ON (B)(6) 2015, IT WAS REPORTED THAT THE PATIENT CONTINUED TO HAVE A SPINAL HEADACHE DESPITE NO FURTHER CSF LEAK. THE PATIENT OPTED TO HAVE THE PUMP AND CATHETER EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396321 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention