BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6422237 · Received March 21, 2017

    Report

    Report Number
    3004209178-2017-06079
    Event Type
    Injury
    Date Received
    March 21, 2017
    Report Date
    April 25, 2017
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND PUMP MOTOR AND GEAR TRAIN ANOMALIES RELATED TO CORROSION AND/OR WEAR AND/OR LUBRICATION, AND STALL DUE TO SHAFT-BEARING. ANALYSIS OF THE UNKNOWN CATHETER/SC CONNECTOR FOUND CORING, TEARS, CUTS IN SEAL THAT MET LEAK CRITERIA PER NDHF1162-113599. VISUAL INSPECTION IDENTIFIED MARKINGS ON THE RETAINING FINGERS IN THE CUP OF THE CONNECTOR. ANALYSIS IDENTIFIED CIRCULAR CORING IN THE BOTTOM OF THE CUP OF THE SC CONNECTOR. THE SHAPE OF THE CORING WAS CONSISTENT WITH THE TIP OF THE CONNECTOR ON THE PUMP. THE CATHETER WAS RETURNED IN SEGMENTS AND FOUND TO BE PATENT. A LEAK WAS IDENTIFIED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. PRODUCT ID 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: CATHETER. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED BY A COMPANY REPRESENTATIVE ON 2017-MAR-21. THE REP CLARIFIED THAT THEY HEALTHCARE PROFESSIONAL WAS ¿UNABLE TO ASPIRATE THE CATHETER, VERY LITTLE DYE WAS SEEN WHEN INJECTED, IF ANY.¿ IT WAS REPORTED THAT THE CATHETER WAS NOT LEFT IN AND WAS ALSO EXPLANTED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS REPORTED BY A HEALTHCARE PROFESSIONAL (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING GABLOFEN (2000 MCG/ML AT 900 MCG/DAY). THE INDICATION FOR USE WAS INTRACTABLE SPASTICITY AND MULTIPLE SCLEROSIS. ON (B)(6) 2017 IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED INCREASED SPASTICITY. IT WAS NOTED THAT THE HCP DID AN INCONCLUSIVE DYE ROTOR STUDY AND DECIDED TO REPLACE THE PUMP AND CATHETER. THE PUMP AND CATHETER WERE REPLACED ON (B)(6) 2017; THE CATHETER WAS LEFT IMPLANTED BUT WAS REPORTEDLY OUT OF SERVICE. NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS MAY HAVE LED TO OR CONTRIBUTE TO THE ISSUE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT AND THE PATIENT¿S STATUS AT THE TIME OF THE REPORT WAS ALIVE WITH NO INJURY. IT WAS NOTED THAT THE PATIENT¿S WEIGHT WAS ASKED BUT UNKNOWN. ADDITIONAL INFORMATION WAS REPORTED BY THE REP ON 2017-MAR-01. IT WAS UNKNOWN WHEN THE PATIENT FIRST STARTED EXPERIENCING INCREASED SPASTICITY AND THE CAUSE OF THE INCREASED SPASTICITY WAS UNKNOWN. IT WAS NOTED THAT A DYE ROTOR STUDY WAS DONE AND WAS INCONCLUSIVE AND THE HCP DECIDED TO REPLACE THE PUMP AND CATHETER ¿RIGHT AWAY THAT EVENING.¿ NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204479 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention