BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3051229 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05925
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 14, 2013
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE PUMP FOUND NO ANOMALY. ANALYSIS OF THE RETURNED PARTIAL CATHETER SEGMENTS REVEALED SC CONNECTOR CORING-TEARS-CUTS IN SEAL; POSSIBLY CAUSED OCCLUSION; NOT MIS-ALIGNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TREMBLING IN ALL EXTREMITIES 'PRETTY MUCH NON-STOP' AND HAD 'JUST RECENTLY BECOME MORE SPASTIC.' THE SYMPTOMS STARTED A FEW DAYS AGO. PER THE REPORTER, THE PATIENT'S MOTHER SAID THIS OFTEN OCCURS WHEN THEY MAKE A CHANGE TO HIS PUMP ALTHOUGH THIS TIME IT WAS 'MUCH WORSE THAN NORMAL' FOR HIM. THE LAST PUMP CHANGE WAS ONE MONTH FROM THE DATE OF THE INITIAL REPORT BUT THE PATIENT 'HAD BEEN FINE' UP UNTIL A 'FEW' DAYS BEFORE THE DAY OF THE INITIAL REPORT. THE HCP WAS NOT SURE THE PATIENT WAS GETTING THE 'PROPER AMOUNT OF BACLOFEN' OR THE PATIENT 'MIGHT' HAVE GOTTEN 'TOO MUCH' AND WANTED THE PUMP INTERROGATED TO CONFIRM THAT IT WAS WORKING PROPERLY. THE PATIENT WAS ADMITTED TO HOSPITAL DUE TO THE SYMPTOMS HE HAD. THE PUMP WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP HAD CONTAINED SALINE FOR THE LAST YEAR. THE PATIENT'S MOTHER FELT LIKE THE PUMP WAS "CAUSING ALL OF THE PATIENT'S SYMPTOMS" SO IN AN EFFORT TO SHOW HER THAT WAS NOT THE CASE THE HEALTHCARE PROFESSIONAL (HCP) FILLED THE PUMP WITH SALINE. THE PATIENT'S SYMPTOMS STILL PERSISTED. THE PUMP WAS REPLACED (B)(6) 2015.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PUMP WAS EXPLANTED, AND PER THE DEVICE MANUFACTURER'S IMPLANT RECORDS, THE CATHETER WAS PARTIALLY REMOVED AT THE TIME OF THE PUMP EXPLANT. THE PUMP WAS REPORTEDLY REMOVED DUE TO A PUMP MALFUNCTION WHICH CAUSED THE PATIENT TO BE VERY SICK OVER A LONG PERIOD OF TIME, AND THE PATIENT HAD "SO MANY ISSUES," WHICH EVENTUALLY CAUSED HIM TO BE HOSPITALIZED AND ON THE VENTILATOR, AND HAD TO BE WEANED OFF HIS PUMP. THERE WERE ALSO REPORTEDLY MANY EPISODES OF OVERDOSE FROM THE BACLOFEN PUMP, WHICH ENDED UP TO THE POINT WHERE THE PUMP WAS TURNED OFF AND WAS SUBSEQUENTLY REMOVED. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT HAD WITHDRAWAL SYMPTOMS ALONG WITH THE OVERDOSE SYMPTOMS WHEN HE HAD THE PUMP. THERE WERE REPORTEDLY NUMEROUS TIMES WHERE HE WAS UNCONSCIOUS. WHEN THE FAMILY TOOK THE PATIENT TO THE HEALTHCARE PROVIDER (HCP), HE WAS RECOVERING. FOR REPORTEDLY 3 YEARS, THE FAMILY DID NOT GET ANY ANSWERS AND HAD MULTIPLE TESTS DONE TO SEE IF THERE WAS SOMETHING ELSE GOING ON. SINCE THE EXPLANT ON (B)(6) 2015, THE PATIENT WAS DOING WELL. FOR THE LAST YEAR THE PUMP HAD BEEN FILLED WITH SALINE AT A MINIMUM RATE AND THE PATIENT WAS BACK TO BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149459 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00018 YR Hospitalization| L| R