BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4213566 · Received October 30, 2014

    Report

    Report Number
    3004209178-2014-20651
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CLARIFIED THE CATHETER DAMAGE WAS IN THE DISTAL SEGMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINAL SURGERY THAT WAS UNRELATED TO THE IMPLANTED INFUSION SYSTEM, THE SURGEON FOUND A TEAR/FRACTURE IN THE DISTAL SEGMENT OF THE CATHETER. IT WAS NOTED THE CATHETER WAS NOT CUT BY THE SURGEON. THE SURGEON REMOVED THE LEAKING PORTION OF THE CATHETER, AND SPLICED THE CATHETER BACK TOGETHER. THE PUMP DOSE WAS RESET TO MINIMUM RATE FOLLOWING THE PROCEDURE, AND THE PATIENT WAS TO FOLLOW-UP WITH HER MANAGING HEALTHCARE PROVIDER (HCP) AFTER DISCHARGE FOR FURTHER PUMP MANAGEMENT. THE MANAGING HCP LATER REPORTED THAT THE SURGEON NOTICED A HOLE IN THE CATHETER, AND IT WAS REPAIRED. THE LOCATION OF THE FRACTURE/HOLE WAS REPORTED TO BE AT THE PROXIMAL (PUMP) SEGMENT. NO CATHETER OR CATHETER SEGMENTS WERE LEFT IN THE INTRATHECAL SPACE UNUSED. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT, AND THE DOSE WAS BEING TITRATED BACK UP. THE PUMP WAS USED TO DELIVER DILAUDID AND BUPIVACAINE. THE EXACT LOCATION OF THE CATHETER DAMAGE (TEAR/HOLE/FRACTURE) REMAINS UNCLEAR BECAUSE THE MANAGING HCP REPORTED THE CATHETER DAMAGE WAS AT THE PROXIMAL (PUMP) SEGMENT, AND THE MANUFACTURING REPRESENTATIVE REPORTED THE CATHETER DAMAGE WAS AT THE DISTAL SEGMENT. FURTHER FOLLOW-UP WAS PERFORMED TO CLARIFY THE LOCATION OF THE CATHETER DAMAGE. IF THIS INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694994 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR