BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2821642 · Received November 6, 2012

    Report

    Report Number
    3004209178-2012-09971
    Event Type
    Injury
    Date Received
    November 6, 2012
    Report Date
    October 9, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709 LOT# J11138R34, IMPLANTED: 2002 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS STILL IN THE HOSPITAL. THE PATIENT DID NOT HAVE NEUROLEPTIC MALIGNANT SYNDROME. THE PATIENT HAD AN ACUTE NEUROLOGIC EVENT AND SEPSIS. IT WAS NOTED THAT THE PRIMARY SUSPECT DRUG WAS PRIALT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE PUMP SYSTEM EXPLANTED DUE TO AN INFECTION, AND THEN SUBSEQUENTLY EXPERIENCED WITHDRAWAL. TWO WEEKS FOLLOWING IMPLANT, THE PATIENT DEVELOPED REDNESS AND SWELLING AT THE SITE OF THE PUMP AND IT WAS DETERMINED THAT THE PATIENT HAD AN INFECTION. THE HEALTHCARE PROVIDER ATTEMPTED TO TREAT THE INFECTION WITH ANTIBIOTICS BUT IT WAS UNSUCCESSFUL, SO THE PUMP AND CATHETER WERE EVENTUALLY EXPLANTED ON (B)(6) 2012. A CULTURE WAS TAKEN AND (B)(6) WAS PRESENT IN THE PUMP POCKET, HOWEVER, NOT AT THE TIP OF THE CATHETER ENTERING THE INTRATHECAL SAC. FOLLOWING EXPLANT, THE PATIENT WAS "NOT DOING WELL". THE REPORTER STATED THAT THE PATIENT MAY HAVE DEVELOPED "NEUROLEPTIC MALIGNANT SYNDROME" AS A RESULT OF INTRATHECAL BACLOFEN (ITB) WITHDRAWAL. AS OF (B)(6) 2012 THE PATIENT WAS BEING MONITORED CLOSELY AND BEING TREATED WITH HIGH DOSE BENZODIAZEPINES AND ORAL BACLOFEN. AS OF (B)(6) 2012, THE REPORTER STATED THAT "THE PATIENT IS RECOVERING NOW, THE PLAN IS TO RE-IMPLANT WHEN INFECTION IS GONE". WHEN THE INITIAL INFORMATION WAS REPORTED, THE MEDICATIONS IN THE PUMP WERE SAID TO BE PRIALT AND BACLOFEN. INFORMATION LATER RECEIVED ON (B)(6) 2012 INDICATED THE PATIENT "WAS NOT ON PRIALT AT THE TIME AE OCCURRED. ONLY BACLOFEN WAS IN THE PUMP". THEN LATER ON (B)(6) 2012 INFORMATION RECEIVED CONTRADICTED THAT INFORMATION, SAYING PATIENT HAD PRIALT AND BACLOFEN IN PUMP. PRIALT DOSE CONCENTRATION WAS SAID TO BE 8.2 MCG/ML AND BACLOFEN 4000MCG/ML. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AFTER ADDITIONAL REVIEW, IT WAS NOTED THAT THE PATIENT WAS TREATED WITH THE BENZODIAZEPINE ATIVAN TO TREAT WITHDRAWAL SYMPTOMS. THE CONCENTRATIONS AND DOSAGES OF BACLOFEN AND PRILAT INFUSED VIA THE PUMP WERE AS FOLLOWS: BACLOFEN 4,000 MG/ML, 1116.3 MCG/DAY; PRIALT 8.24 MCG/ML, 2.2885 MCG/DAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R