BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4853990 · Received June 18, 2015

    Report

    Report Number
    3004209178-2015-11870
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    May 28, 2015
    Report Date
    May 28, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS OF THE PUMP FOUND NO ANOMALY. THE LAB DID NOT ENCOUNTER ANY RESERVOIR ACCESS ISSUES DURING THE NON DESTRUCTIVE PROCESS. ALL PUMP LOGS ARE CLEAN, MEANING, NO MOTOR STALLS, MOTOR STALL RECOVERIES, OR ERRORS OF ANY KIND HAD EVER HAPPENED WITH THIS PUMP. THE FLUID PATH WAS DESTRUCTIVELY ANALYZED WITH NO ANOMALIES FOUND. EVAL CODE-RESULT NO LONGER APPLIES. EVAL CODE-CONCLUSION REPLACED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8835, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON 2015 (B)(6) THE HEALTHCARE PROVIDER (HCP) HAD DIFFICULTY FILLING THE PUMP DURING PUMP REFILL. THE PATIENT HAD COMPLAINED OF LACK OF THERAPY. THE PUMP STILL HAD THE MAJORITY OF ITS BATTERY LIFE BUT THE HCP ELECTED TO REPLACE THE PUMP. THE CATHETER WAS ASPIRATED AND THE HCP WAS ABLE TO GET 2ML OF DRUG. IT WAS DETERMINED THAT THE CATHETER WAS PATENT. IT WAS UNKNOWN WHAT THE PUMP PERFORMANCE ISSUE WAS. OTHER TROUBLESHOOTING WAS UNKNOWN. THE PUMP WAS EXPLANTED AND REPLACED ON 2015 (B)(6) WITH A LARGER 40ML PUMP. THE PATIENT¿S THERAPY WAS CONTINUED AFTER THE REPLACEMENT; HOWEVER, OUTCOME WAS NOT PROVIDED. THE DEVICE SYSTEM DELIVERED MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395789 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention