BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2963612 · Received February 15, 2013

    Report

    Report Number
    3007566237-2013-00497
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 17, 2013
    Report Date
    July 26, 2016
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8784, SERIAL# UNKNOWN. PRODUCT TYPE: CATHETER: PRODUCT ID 8784, SERIAL# UNKNOWN. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHEN THE PUMP WAS TO BE REPLACED, THEY FOUND THAT THE OLD CATHETER HAD BEEN SEVERED. IT WAS NOTED THAT IT COULD NOT BE CONFIRMED IF THE ENTIRE CATHETER WAS REMOVED, OR LEFT IN PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PROXIMAL CATHETER REVISION AND THE LABELING INFORMATION WAS INCORRECT ON THE REVISION KIT. IT WAS NOTED THAT THE BOX STATED THE CATHETER WAS 73 CM WHEN IT WAS ACTUALLY 73.7 CM. THE PATIENT OUTCOME WAS UNKNOWN, AND NO SIGNS OR SYMPTOMS WERE REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS LATER ADDED THAT DURING THE PREVIOUSLY REPORTED ROUTINE PUMP REPLACEMENT, IT WAS NOTED THERE WAS "NO CEREBROSPINAL FLUID DRIP" THEREFORE THE ENTIRE CATHETER WAS REPLACED AND THEN A PROXIMAL CATHETER REVISION WAS DONE. THE EFFECTED CATHETER WAS EXPLANTED AND WILL NOT BE RETURNED. IT WAS NOTED THAT THE PATIENT DID NOT EXPERIENCE ANY PROBLEM. TROUBLESHOOTING DONE WAS THEY "TRIED" TO DRAW BACK FROM THE CATHETER ACCESS PORT "TO DETERMINE PATENCY OF EXISTING CATHETER." PATIENT OUTCOME NOTED AS "IMPROVED THERAPY," NO FURTHER COMPLICATIONS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED BY THE COMPANY REPRESENTATIVE ON (B)(6) 2016. PUMP LOGS WERE RETURNED WHICH NOTED THAT THERE WAS A CATHETER REPLACEMENT ON (B)(6) 2013, THE CATHETER TIP WAS PLACED AT T5, AND THE OLD SPINAL SEGMENT WAS STILL IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68952 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 00022 YR Required Intervention