BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2930932 · Received January 28, 2013

    Report

    Report Number
    3007566237-2013-00284
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    July 13, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND. FINAL ANALYSIS OF THE CATHETER REVEALED NON-SIGNIFICANT INDENT IN THE SEAL OF THE SUTURELESS CONNECTOR WHICH DID NOT AFFECT INFUSION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER: PRODUCT ID 8709, LOT# L55916, IMPLANTED: (B)(6) 2000, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CATHETER DYE STUDY WAS PERFORMED FOLLOWING A PATIENT'S FALL. THE STUDY SHOWED A LEAK AND INDICATED A CATHETER BREAK IN THE CATHETER TRACK. NORMAL BATTERY DEPLETION OF THE PATIENT'S PUMP WAS ALSO REPORTED AND INDICATED AN ERI AT 7 MONTHS. THE CATHETER WAS NOTED TO HAVE BEEN REPLACED DUE TO A TEAR IN THE CATHETER. THE PUMP WAS SCHEDULED ELECTIVELY SO THE PHYSICIAN OPTED TO REPLACE BOTH. THE PATIENT WAS NOTED TO HAVE EXPERIENCED "LESS THAN 50% THERAPY RELIEF." THE MEDICATION USED WITHIN THE SYSTEM WAS INFUMORPH. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER ON 21-JUN-2016 AND IT WAS REPORTED THAT THE PATIENT "FELL ON HIS PUMP AND CRUSHED IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37608 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention