BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2997768 · Received March 11, 2013

    Report

    Report Number
    3007566237-2013-00745
    Event Type
    Injury
    Date Received
    March 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2383-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATHETER: MODEL 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013. ACCESSORY: MODEL 8590-1, LOT# N232313, IMPLANTED: (B)(6) 2010, EXPLANTED: UNK. (B)(4). FINAL ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND. CATHETER RETURNED IN THREE PIECES. FINAL ANALYSIS OF THE CATHETER REVEALED SUTURELESS CONNECTOR CORING/TEARS/CUTS IN SEAL. MEETS LEAK CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER AND PUMP WERE REPLACED DUE TO LEAKING AROUND CATHETER. NO PATIENT INJURY. OUTCOME NOTED AS RECOVERED WITHOUT SEQUELAE. THE DEVICE SYSTEM WAS USED TO INFUSE COMPOUNDED BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101018 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 YR Required Intervention