BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3882427 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-11788
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE CATHETER. (B)(4) .

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION VERIFIED THAT THE PREVIOUS (OLD) CATHETER WAS CUT, TIED OFF AND LEFT IN PLACE BUT NOT IN USE. A NEW CATHETER WAS USED. NO FURTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE PATIENT HAD FENTANYL IN THE PUMP AS THE TIME OF REPORT AND THEY WERE TRYING TO INCREASE THE DOSING BUT PATIENT WAS HAVING INTOLERABLE SIDE EFFECTS. THE MANUFACTURER REPRESENTATIVE DID NOT KNOW WHEN THE SYMPTOMS HAD STARTED OR WHAT THE SYMPTOMS WERE ADDITIONAL INFORMATION RECEIVED REPORTED THE CATHETER WAS REVISED TO "PULL IT DOWN LOWER" DUE TO POOR TOLERANCE WITH THE DOSAGE INCREASE. THE CATHETER HAD ORIGINALLY BEEN PLACED HIGH DUE TO USE OF BACLOFEN PREVIOUSLY. THE EXACT SYMPTOMS WERE NOT KNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS REVISING A CATHETER ON THE DAY OF REPORT. IT WAS REPORTED THAT THE PATIENT WAS INITIALLY IMPLANTED WITH BACLOFEN AND PLACED AROUND T-4. IT WAS NOTED THAT ¿BACLOFEN WAS AT THE TIME OF IMPLANT¿, AND IT WAS UNKNOWN WHY IT WAS SWITCHED TO FENTANYL. IT WAS NOTED THAT THE PHYSICIAN WANTED TO LOWER THE CATHETER AND HE OPTED TO CUT THE EXISTING SEGMENT, TIE IT OFF AND IMPLANT A NEW DISTAL SEGMENT. THE PHYSICIAN CUT THE PART OF THE DISTAL SEGMENT AND LEFT THE REMAINDER SEGMENT IMPLANTED AND TIED IT OFF. THE ORIGINAL CATHETER WAS 47.5CM, 34.5CM REMAINED AND WAS TIED OFF, 13CM WAS REMOVED, 6CM WAS TRIMMED, SO 7CM WAS LEFT AND USED IN THE NEW DISTAL CATHETER. IT WAS REPORTED THAT THE NEW DISTAL PIECE DID NOT HAVE MEDICATION AND WAS CLOSEST TO THE SPINE, PRIMING BOLUS WAS CALCULATED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT PAIN WAS A SYMPTOM RELATED TO THE EVENT. THE CATHETER ISSUE WAS THE PLACEMENT WAS CAUSING THE PAIN. THE DISTAL PART OF THE CATHETER WAS THE ISSUE. THE CATHETER ISSUE WAS IDENTIFIED VIA CT SCAN. IT WAS REPORTED THAT CATHETER SEGMENTS WERE NOT LEFT IN THE INTRATHECAL SPACE. IT WAS REPORTED THAT IT WAS UNKNOWN HOW THE PATIENT WAS DOING; PATIENT HAD NOT BEEN SEEN FOR A FOLLOW UP OFFICE VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357199 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention