BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3802789 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08808
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    April 17, 2014
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER REVEALED A KINK IN THE CATHETER BODY. THE PROXIMAL SIDE OF THE CATHETER WAS RETURNED WITH A SUTURE TIED AROUND IT. BLEACH WAS UNABLE TO BE PASSED THROUGH THE CATHETER. IT WAS SOAKED IN BLEACH FOR AN HOUR AND THE SUTURE DISSOLVED. AT THIS POINT, THE PATENCY WAS POSSIBLE.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON THE DATE OF THIS REPORT THAT DURING REFILLS THEY ¿EXPECT LESS BUT GET MORE¿. PER REPORTER, PATIENT WAS SCHEDULED FOR A ROLLED STUDY ON (B)(6) 2014. PATIENT STATUS AT TIME OF THIS REPORT WAS NOTED AS ¿ALIVE - NO INJURY¿, WITH NO REPORTED SYMPTOMS. DRUG IN THE PUMP WAS NOT KNOWN TO THE REPORTER. ADDITIONAL INFORMATION WAS LATER RECEIVED THAT THE HEALTHCARE PROVIDER (HCP) PREFORMED A DYE STUDY AND PUMP ROLLER STUDY ON THE AFTERNOON OF (B)(6) 2014 AS SCHEDULED. THEY WERE UNABLE TO ASPIRATE CATHETER WHEN PATIENT WAS SUPINE. THEY THEN HAD PATIENT LAY SLIGHTLY LATERAL AND CATHETER COULD BE ASPIRATED WITH EASE. HCP THEN HAD PATIENT MOVE BACK TO SUPINE AND ONCE AGAIN GOT NO FLOW. HE ALSO USED 'ISOVUE FOR DYE STUDY' BUT THE CATHETER DID NOT INDICATE LEAK. PUMP CATHETER CLEARED SO HCP PRIMED THE CATHETER AND WATCHED PUMP ROLLERS TURN UNDER FLOURO AND THEY DID TURN. PATIENT WAS ASKED BY THE HCP AND INDICATED THAT SHE DOES GET RELIEF SOMETIMES AND NOT OTHERS. A CATHETER REVISION WAS TO BE PLANNED PER HCP. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE HEALTH CARE PROVIDER (HCP) REPLACED THE 8780 CATHETER WITH A NEW 8780 ON THE DATE OF THIS FOLLOW UP REPORT. THE NEW CATHETER WAS PATENT AND CHECKED AFTER IT WAS CONNECTED TO THE PUMP. THE HCP WAS REPORTEDLY GOING TO TRY TO TIE OFF THE SPINAL SEGMENT BUT IT CAME OUT OF THE INTRATHECAL SPACE. THEREFORE, THE ENTIRE OLD CATHETER WAS REMOVED AND REPLACED. IT WAS FURTHER REPORTED THE DEVICE DELIVERED DILAUDID 2MG/ML WITH BUPIVACAINE 6MG/ML CONCENTRATION, COMPOUNDED. THE DOSE PRIOR TO THE REVISION WAS 1.7558 MG/DAY AND IT WAS REDUCED TO 1.23MG/DAY POST THE CATHETER REPLACEMENT. THE EXACT SYMPTOMS THE PATIENT EXPERIENCED CONSISTED OF "INTERMITTENT RELIEF/VOLUME DISCREPANCY". FOLLOWING THE SURGERY, THE PATIENT WAS REPORTEDLY DOING WELL. IT WAS THEN REPORTED THE CATHETER HAD BEEN TIED OFF BUT CAME OUT OF THE INTRATHECAL SPACE AFTER SO IT WAS "TAGGED" FOR RETURN. THE CATHETER WAS SENT TO PATHOLOGY AND IT WAS REPORTED "THEY CALL WHEN READY TO RELEASE". NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280522 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention