BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3953703 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-13453
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS TO HAVE A CATHETERGRAM TO CHECK FOR A GRANULOMA. IT WAS FURTHER REPORTED THE PATIENT WAS HAVING INCREASED BACK PAIN IN THE AREA OF THE CATHETER AND THE PUMP DOSAGE WAS INCREASED, BUT THE PATIENT WAS NOT NOTICING A DIFFERENCE IN PAIN LEVEL. A MAGNETIC RESONANCE IMAGING (MRI) WAS ORDERED AND NOTHING WAS SEEN. IT WAS ALSO REPORTED A DYE STUDY WAS TO BE PERFORMED ON 2014-07-08. THE PUMP WAS BEING USED TO DELIVER MORPHINE AND BUPIVACAINE. ADDITIONAL INFORMATION RECEIVED REPORTED THE MRI LUMBAR SHOWED NO GRANULOMA. IT WAS ALSO REPORTED DURING THE DYE STUDY, CEREBROSPINAL FLUID (CSF) COULD NOT BE ASPIRATED THROUGH THE CATHETER PORT AND THE DYE STUDY WAS ABORTED. IT WAS NOTED THE PATIENT NEEDED TO HAVE THE PUMP AND CATHETER REPLACED, BUT A DATE WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE CATHETER WAS FRACTURED. THE CATHETER BROKE IN HALF IN (B)(6) 2014. THE PATIENT DID NOT KNOW ABOUT IT UNTIL THEY SHOWED PAIN SYMPTOMS. A DYE STUDY SHOWED A BLOCKAGE. IT WAS LATER REPORTED THAT A DYE STUDY WAS PERFORMED ON (B)(6) 2014 AND THEY WERE UNABLE TO ASPIRATE, SO THE PROCEDURE WAS ABORTED. IT WAS NOTED THAT THE CATHETER WAS FLOATING AROUND IN THEIR BODY. A CATHETER REVISION OCCURRED ON (B)(6) 2014. LATER A CATHETER REVISION DATE OF (B)(6) 2014 WAS REPORTED. A BRAND NEW CATHETER WAS IMPLANTED IN AUGUST; HOWEVER, A PIECE OF THE OLD CATHETER WAS LEFT IN THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432405 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention