BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6138022 · Received December 1, 2016

    Report

    Report Number
    3004209178-2016-24945
    Event Type
    Injury
    Date Received
    December 1, 2016
    Report Date
    February 3, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, EXPLANTED: (B)(6) 2016. PRODUCT TYPE CATHETER. ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. 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.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE PUMP SERIAL NUMBER (B)(4) DID NOT REVEAL ANY ANOMALIES. THE RETURNED PUMP PASSED ALL FUNCTIONAL TESTING IN THE RETURNED PRODUCT ANALYSIS LAB.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 2016-DEC-15 FROM THE REP STATING THAT THE DEVICE WAS SENT BACK. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP WHEN THE DEVICE WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A DEVICE MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS RECEIVING 4000 MCG/ML BACLOFEN AT 665.7 MCG/DAY VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY AND MULTIPLE SCLEROSIS. IT WAS REPORTED THAT THE PATIENT HAD WHAT APPEARED TO BE A SUPERFICIAL INFECTION AND THE PUMP WAS REPLACED. IT WAS NOTED THAT THE POCKET WAS NOT INFECTED. THERE WAS NO DIAGNOSTIC TESTING OF THE PUMP AND NO OTHER INTERVENTIONS OR ACTIONS WERE TAKEN FOR THE PUMP. THE ISSUE WAS CONSIDERED TO BE RESOLVED AND THE PATIENT WAS CONSIDERED "ALIVE - NO INJURY". THE EVENT DATE WAS UNKNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON 2016-DEC-01 REPORTED THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THE EVENT TO THE MANUFACTURER REPRESENTATIVE, AND THE DEVICE WAS BEING SENT BACK FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790375 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention