BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3772262 · Received April 25, 2014

    Report

    Report Number
    3004209178-2014-08092
    Event Type
    Injury
    Date Received
    April 25, 2014
    Report Date
    April 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A DYE STUDY WAS PERFORMED BECAUSE A CEREBROSPINAL FLUID LEAK WAS SUSPECTED. THE REPORTER STATED, THE LEAK WAS SUSPECTED BECAUSE, THERE WAS A SOFT BUMP AROUND THE INCISION ON THE PATIENT¿S BACK. IT WAS NOTED, THE DYE STUDY LOOKED FINE. IT WAS FURTHER NOTED, THE PATIENT WAS GETTING GOOD RELIEF AND DID NOT HAVE A HEADACHE OR ANYTHING. THE REPORTER STATED, THE BUMP WAS DISCOVERED YESTERDAY. THE PUMP CONTAINED MORPHINE. ADDITIONAL INFORMATION RECEIVED REPORTED, THE SOFT BUMP WAS NOT DEVICE RELATED AND THE CAUSE WAS NOT DETERMINED. IT WAS NOTED, THE PATIENT HAD NOT DEVELOPED ANY SYMPTOMS. IT WAS FURTHER NOTED THAT NO ACTIONS OR INTERVENTIONS WERE TAKEN OR PLANNED. THE REPORTER STATED, THE PATIENT HAD 50% RELIEF. ADDITIONAL INFORMATION RECEIVED REPORTED, THE PATIENT HAD A CSF LEAK. THE REPORTER STATED, THE SYSTEM WAS IMPLANTED 2.5 MONTHS AGO AND IT WAS DETERMINED THE PATIENT HAD A CSF LEAK. IT WAS NOTED THAT A DYE STUDY DID NOT SHOW ANY ISSUES. IT WAS FURTHER NOTED, THE LEAK WAS COMING AROUND THE CATHETER AND WAS CREATING A SEROMA AT THE SPINAL INCISION. THE REPORTER STATED THAT A REVISION WAS PERFORMED AND A NEW DISTAL SECTION OF CATHETER WAS IMPLANTED. THE REPORTER FURTHER STATED THAT DURASEAL WAS USED ON THE PREVIOUS HOLE. IT WAS NOTED, THE PATIENT HAD BEEN IN THE HOSPITAL SINCE 2014 (B)(6) WITH FLUID IN THEIR BACK POCKET SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252606 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R