BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3071073 · Received April 22, 2013

    Report

    Report Number
    3007566237-2013-01380
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE PUMP LOGS REVEALED NO ANOMALIES. THE LOG INFORMATION INDICATED THE PUMP WAS CLOSE TO THE ELECTIVE REPLACEMENT INDICATOR (ERI) WHICH WAS CLOSE TO END OF LIFE. DISPENSE TESTING FAILED AND SHOWED OVER DISPENSING. INFUSION TESTING WAS PERFORMED TO SEE IF A REPEATED PATTERN APPEARED ON THE GRAPHING AT THE SAME RATE AS DISPENSE TESTING BUT FOR A LONGER PERIOD OF TIME. THE INFUSION TESTING ALSO FAILED AND DISPLAYED AN OVER INFUSION. AN X-RAY TO VERIFY ROLLER POSITION BEFORE THE STOP PUMP TESTING WAS TAKEN. STOP PUMP TESTS SHOWED THAT WHEN THE PUMP WAS PROGRAMMED TO STOP, FLUID WAS NO LONGER FLOWED. DESTRUCTIVE ANALYSIS DISCOVERED SIGNIFICANT AMOUNTS OF FOREIGN MATERIAL (FM) IN THE PUMP HEAD COMPARTMENT, PUMP HEAD AND ON THE SURFACE OF THE PUMP TUBE. A STANDARD PUMP TUBE LEAK TEST DID NOT SHOW A HOLE IN THE PUMP TUBE. THE PUMP HEAD HAD SIGNIFICANT AMOUNTS OF FM CAKED IN IT TO IMPEDE PROPER OCCLUSION OF THE PUMP TUBE. THE PUMP TUBE ALSO WAS EXTREMELY DISCOLORED, HARDENED AND HAD A LOSS OF ELASTICITY. THE COMBINATION OF MECHANICAL AND CHEMICAL STRESSES MAY HAVE CONTRIBUTED TO THE CHANGE IN THE CROSS SECTION OF THE PUMP TUBE. IT WAS BELIEVED THAT THESE TWO FACTORS CAUSED THE OVER INFUSION. THE FM WAS SENT FOR FURTHER ANALYSIS WHICH TESTED POSITIVE FOR BUPIVACAINE AND FENTANYL.

    Description of Event or Problem · 1

    THIS PUMP WAS EXPLANTED, RETURNED, AND REPORTEDLY NOT RELATED TO AN EVENT NOR A SUSPECTED MALFUNCTION. THERE WERE NO PATIENT SYMPTOMS REPORTED. THIS DEVICE SYSTEM DELIVERED BUPIVACAINE, FENTANYL, AND HYDROMORPHONE. THE DEVICE UNDERWENT ROUTINE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172496 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR