BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6085437 · Received November 8, 2016

    Report

    Report Number
    3004209178-2016-23407
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 10, 2016
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-9, LOT# N223114, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: 2010-03-11 EXPLANTED: 2016-11-02 PRODUCT TYPE CATHETER. 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

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE CAUSE OF THE SURGEON NOT BEING ABLE TO DRAIN THE CATHETER WAS UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A DEVICE MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS RECEIVING 2000 MCG/ML BACLOFEN AT 350.1 MCG/DAY VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY AND OTHER SPASTICITY. IT WAS REPORTED THAT THE PATIENT HAD A ROUTINE ERI PUMP REPLACEMENT ON (B)(6) 2016. DURING THE REPLACEMENT THE SURGEON WAS UNABLE TO DRAIN THE CATHETER FOR CEREBROSPINAL FLUID (CSF) AND THE CATHETER WAS REMOVED. NO SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737130 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention