BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3950301 · Received July 22, 2014

    Report

    Report Number
    3007566237-2014-02031
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS - CORRECTED/ADDITIONAL INFORMATION: PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: CATHETER; PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. CORRECTED INFORMATION: ADDITIONAL DEVICE INFORMATION WAS RECEIVED WHICH NOW INDICATES THAT THE CORRECT MANUFACTURING SITE NUMBER IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN COULD NOT CLEAR THE CATHETER DURING THE PUMP REPLACEMENT PROCEDURE, SO WAS QUESTIONING CATHETER FUNCTION. THE PHYSICIAN THEN DECIDED TO INJECT CONTRAST INTO THE CATHETER (THE PATIENT RECEIVED A 5.24 MG BOLUS) AND THEN THE CATHETER WAS CLEAR. THE PATIENT HAD NO SYMPTOMS AT THE TIME OF THIS REPORT. THE DEVICE SYSTEM WAS DELIVERING MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE PATIENT WAS DOING WELL. THE PATIENT HAD NO ADVERSE EFFECTS FROM THE PUMP REPLACEMENT OR BOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428595 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR