BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2894044 · Received January 3, 2013

    Report

    Report Number
    3004209178-2013-00071
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 5, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: UNK. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CATHETER DISCONNECTION WAS SUSPECTED. IT WAS STATED THAT WHILE PATIENT WAS SEATED IN THE SHOWER CHAIR, A PALPABLE "BULGE" WAS FELT ON THE PATIENT'S BACK NEAR THE CATHETER. THE PATIENT WAS SCHEDULED FOR AN EVALUATION THE NEXT DAY ON (B)(6) 2012. PER THE REPORTER THE PATIENT WAS ASYMPTOMATIC AND CLINICALLY WAS DOING "JUST FINE." DRUG DELIVERED VIA THE DEVICE WAS BACLOFEN; PATIENT HAD ORAL BACLOFEN AVAILABLE IF NEEDED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED MULTIPLE EVENTS OF WITHDRAWAL AND SURGICAL REVISIONS. FOLLOWING THE INITIAL EVENT EXPERIENCE AS PREVIOUSLY REPORTED, THE HEALTHCARE PROVIDER (HCP) ATTEMPTED A CATHETER DYE STUDY WHEN THE PATIENT STARTED TO EXPERIENCE WITHDRAWAL AND SYMPTOMS OF INCREASED SPASTICITY, AND PRURITUS. DURING THE DYE STUDY, THE HCP WAS UNABLE TO ASPIRATE THE CATHETER. THE CATHETER WAS FOUND TO HAVE MIGRATED, AND A CATHETER REVISION WAS DONE ON (B)(6) 2012, AT WHICH TIME THE HCP SPLICED A NEW CATHETER ONTO THE EXISTING ONE. APPROXIMATELY 10 DAYS POST MIGRATION REVISION, THE PATIENT STARTED AGAIN TO HAVE "MAJOR WITHDRAWAL" AND WAS IN THE ICU AT THE HOSPITAL, SINCE THE DATE OF (B)(6) 2012, WITH ITCHING, SCRATCHING AND RETURN OF SPASTICITY. ANOTHER DYE STUDY WAS ATTEMPTED BY THE HCP, BUT AGAIN THE HCP WAS UNABLE TO ASPIRATE. ON (B)(6) 2013, THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR ANOTHER REVISION, AT WHICH TIME WHEN THE POCKET WAS OPENED, THE CATHETER WAS FOUND TO BE DISCONNECTED FROM THE PUMP. THE HCP REMOVED THE OLD CONNECTOR AND REPLACED THAT WITH A NEW CONNECTOR SEGMENT, AND AT THE SAME TIME REPLACED THE PUMP. THERE WAS NO ALLEGATION OF PUMP MALFUNCTION, AND THE HCP CHOSE TO REPLACE IT AS IT WAS DUE TO BE REPLACED IN 2 YEARS. FOLLOWING THE REVISION, THE PATIENT HAD A NEW PUMP AND CATHETER. THE MEDICATION BEING DELIVERED WAS BACLOFEN. THE PATIENT OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT YET AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3363 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R