BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3013274 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-03987
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    January 15, 2013
    Report Date
    February 20, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS OF THE CATHETER NOTED THE CATHETER WAS RETURNED IN SEGMENTS. A NON-SIGNIFICANT INDENT WAS SEEN IN THE CUP OF THE SC ( SUTURE LESS) CONNECTOR. IT WAS DETERMINED TO BE NON-SIGNIFICANT BECAUSE NOT ENOUGH OF THE INDENT WAS LOCATED IN THE SILICONE SEAL DOWN IN THE SC CUP AND THEREFORE DID NOT MEET THE CRITERIA FOR OCCLUSION. THE DISPENSING HOLES WERE INSPECTED PRIOR TO DECONTAMINATION AND NO MATERIAL WAS NOTED IN THE DISPENSING HOLES. BOTH SEGMENTS WERE PATENT WHEN TESTED AND DID NOT SHOW ANY LEAKS. THE ALLEGATION WAS NOT VERIFIED IN LAB TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REPORTED POOR, LESS THAN 50%, PAIN RELIEF. A PUMP STUDY WAS DONE ON (B)(6) 2013 AND CEREBRAL SPINAL FLUID (CSF) COULD NOT BE DRAWN. A REVISION WAS PERFORMED AND CSF WAS WITHDRAWN VIA THE CATHETER ACCESS PORT (CAP) AFTER THE PUMP WAS REMOVED FROM THE POCKET. A NEW CATHETER WAS IMPLANTED. THERE WAS NO PATIENT INJURY REPORTED. THIS DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115658 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention