BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2502704 · Received March 24, 2012

    Report

    Report Number
    3004209178-2012-01825
    Event Type
    Injury
    Date Received
    March 24, 2012
    Date of Event
    September 17, 2011
    Report Date
    March 9, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATHETER PROXIMAL REV SEG MODEL: 8596SC SERIAL #: (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: UNK; CATHETER DISTAL REV SEG MODEL: 8598A SERIAL #: (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: UNK; CATHETER DISTAL REV SEG MODEL: 8598A SERIAL #: (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: UNK; PROGRAMMER MODEL: 8835, SERIAL #: (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PUMP WAS REFILLED WITH A DOSE INCREASE BY 10% ON (B)(6) 2011 AND THE FOLLOWING WEEKEND, I.E. 5 DAYS LATER, PATIENT EXPERIENCED SYMPTOMS OF CONFUSION. IT WAS LATER THAT THE CAUSE OF THE EVENT WAS UNKNOWN; PATIENT WAS ADMITTED TO THE HOSPITAL WITH PNEUMONIA. IT WAS ADDED THAT PATIENT WAS GIVEN A PRESCRIPTION FROM HIS PRIMARY FOR ORAL BACLOFEN TO BE TAKEN ONLY IF HIS PUMP MALFUNCTIONED; HOWEVER, THE PATIENT WAS TAKING ORALS ALONG WITH HIS INTRATHECAL BACLOFEN WHICH CREATED HIS SIDE EFFECTS. PATIENT RECOVERED WITHOUT SEQUEL. DRUGS DELIVERED VIA THE DEVICE WERE COMPOUNDED BACLOFEN, MORPHINE, BUPIVACAINE AND CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Hospitalization