BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2895477 · Received January 3, 2013

    Report

    Report Number
    3004209178-2013-00123
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 7, 2012
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT # L55919, IMPLANTED: (B)(6) 1998, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT# L55919, IMPLANTED: (B)(6) 1998, PRODUCT TYPE CATHETER; PRODUCT ID 8709, LOT# L55919, IMPLANTED: (B)(6) 1998, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS OF THE PUMP REVEALED NO ANOMALIES. ANALYSIS OF THE CATHETER REVEALED THE PUMP CONNECTOR SUTURE RING WAS BROKEN. IN ADDITION, THE CATHETER HAD INCOMPLETE DISPENSING HOLES RELATED TO A MANUFACTURING ISSUE.

    Description of Event or Problem · 1

    IN (B)(6) 2012, FOLLOWING THE PUMP REFILL, SOME SWELLING/FULLNESS WAS NOTED AT THE PUMP POCKET SITE. THE PATIENT DID HAVE SOME SYMPTOM CHANGE/SOME MINOR WITHDRAWAL SYMPTOMS, BUT THAT RESOLVED BY ITSELF. A CAP (CATHETER ACCESS PORT) STUDY WAS DONE AND DID NOT SHOW ANY ISSUES WITH THE CATHETER. IN (B)(6) 2012, THE PUMP WAS REFILLED WITH 40ML OF LIORESAL. WHEN THE NEEDLE WAS TAKEN OUT OF RESERVOIR, CLEAR FLUID CAME OUT OF THE NEEDLE INSERTION SITE. THEY ASPIRATED OUT THE CONTENTS OF PUMP AND GOT A FULL 40ML BACK AND THEN REINSERTED THE DRUG. SOME SWELLING/FULLNESS WAS NOTED AT THE PUMP POCKET SITE. THE PATIENT DID NOT HAVE WITHDRAWAL SYMPTOMS. AN X-RAY OF THE PUMP WAS DONE AND IT WAS DETERMINED THAT THE PUMP HAD A FULL RESERVOIR. THEY WERE SENDING THE PATIENT HOME WITH AN ABDOMINAL BINDER. THERE WAS NO REDNESS AT PUMP SITE. IN (B)(6) 2012, FOLLOWING THE REFILL, THE PATIENT HAD POCKET SWELLING. THE RESIDUAL VOLUME WAS ONLY ABOUT 1 ML OFF; APPROXIMATELY 4 ML EXPECTED AND 5 ML REMOVED. ON (B)(6), THE PUMP WAS REFILLED WITH BACLOFEN 2000 MCG/ML AND REPROGRAMMED TO THE PREVIOUS SETTINGS (FLEX INFUSION MODE 690 MCG/DAY). IT WAS NOTED THAT "AT SOME POINT" THE PUMP HAD BEEN PROGRAMMED TO FLEX MODE AND THIS CHANGE IN INFUSION SEEMED TO HELP. THE PATIENT REMAINED ON ORAL BACLOFEN 10 MG 2X/DAY FROM EARLIER THIS YEAR WHEN HE EXPERIENCED ACUTE WITHDRAWAL SYMPTOMS AND WAS HOSPITALIZED FOR WHAT WAS THOUGHT TO BE A CATHETER MICROFRACTURE. DURING THE REFILL, AFTER THE NEEDLE WAS REMOVED, SOME FLUID CAME OUT OF NEEDLE HOLE (1ML). THE RESIDUAL VOLUMES MATCHED APPROXIMATELY 1.5 ML EXPECTED AND REMOVED AT THE REFILL. A LATERAL VIEW OF THE PUMP WAS TAKEN AND IT APPEARED FULL. AFTER THE REFILL, THE PUMP SITE WAS NOTED TO BE "FULL APPEARING WITH SUBCUTANEOUS TISSUE, BUT NO FLUID WITHIN POCKET." ABOUT 6-8 HOURS LATER, THE PATIENT'S MOTHER NOTICED PUMP POCKET SWELLING; IT WAS EDEMATOUS. THE PATIENT ALSO STARTED HAVING WITHDRAWAL TYPE SYMPTOMS INCLUDING ITCHING. AROUND 11PM, THE PATIENT WAS COMPLAINING OF MUSCLE SPASMS. THE HOSPITAL WAS CALLED AND THEY RECOMMENDED GIVING AN EXTRA DOSE OF ORAL BACLOFEN. THE PATIENT WAS ABLE TO SLEEP FROM 12AM TO 3:30AM AND THEN WOKE UP AND COULD NOT GET COMFORTABLE. THE PATIENT WAS THEN GIVEN DIAZEPAM. HE FELL ASLEEP AGAIN AND THEN WOKE UP AT 8:30AM AND WAS GIVEN ORAL BACLOFEN 10 MG. THE CLIN IC WAS CONTACTED AND IT WAS RECOMMENDED THAT THE PATIENT COME IN FOR AN URGENT EVALUATION. THE PATIENT WAS SEEN IN THE CLINIC. THE PATIENT HAD INTERMITTENT TRIPLE FLEXION MOVEMENT, MORE SO IN LEFT LOWER EXTREMITY WITH TACTILE STIMULATION. HE WAS AWAKE AND ALERT AND STATED THAT HE WAS ITCHING, BUT LESS SO IN COMPARISON TO THE PREVIOUS WITHDRAWAL SYMPTOMS IN (B)(4) 2012. THE PATIENT WAS UNCOMFORTABLE WHEN HAVING THE MUSCLE SPASMS IN LOWER EXTREMITIES. THE PUMP POCKET WAS NOTED TO BE MORE EDEMATOUS AND MORE SPONGY FEELING IN COMPARISON TO THE DAY BEFORE. IT WAS MILDLY TENDER UPON PALPATION. IT WAS NOTED THAT THE SIZE OF THE POCKET SWELLING PREVIOUSLY SEEMED TO HAPPEN MORE QUICKLY THAN THIS TIME. RADIOLOGIC STUDIES WERE DONE. THE PUMP SERIES OBTAINED SHOWED THE CATHETER TO BE WITHIN THE INTRATHECAL SPACE AND IT APPEARED INTACT. THE PROXIMAL PORT CONNECTION APPEARED TO BE RATHER ANGULATED. THERE WAS NO SIGNIFICANT CHANGE FROM PREVIOUS X-RAY IN (B)(6). ALSO ON LATERAL VIEW, THE BELLOWS OF THE PUMP RESERVOIR APPEARED TO BE FULL, SUGGESTING FULL CAPACITY WITH INTRATHECAL BACLOFEN. THE PUMP WAS INTERROGATED; THE LOGS WERE PRINTED AND SHOWED NO ACTIVITY SINCE YESTERDAY AT 9:32AM. A 100 MCG BOLUS WAS GIVEN. TWO HOURS AFTER THE BOLUS THE PATIENT REPORTED THAT HE FELT MORE COMFORTABLE AND THE PRURITUS WAS RESOLVED; DECREASED SPASTICITY WAS ALSO NOTED IN THE LOWER EXTREMITIES. A PRESCRIPTION WAS WRITTEN FOR BACLOFEN 20 MG 3X/DAY, WHICH COULD BE STARTED THAT EVENING. IT WAS NOTED THAT THE PATIENT HAD DIFFICULTY WITH URINATION EARLIER IN THE MORNING, BUT WAS ABLE TO VOID DURING THE CLINIC VISIT. THE PLAN WAS TO MONITOR THE PATIENT. THEY RECOMMENDED THAT THE PATIENT WEAR AN ABDOMINAL BINDER UNTIL THE EDEMA RESOLVED. A FOLLOW-UP VISIT WAS SCHEDULED FOR (B)(6) 2013 OR SOONER IF PATIENT HAD ONGOING SYMPTOMS.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PUMP AND CATHETER WERE EXPLANTED. REPORTEDLY, THE CATHETER HAD A BREAK, TEAR OR HOLE. THERE WAS NO P ATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA. THE DEVICE SYSTEM DELIVERED LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2550 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00026 YR Hospitalization