BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3062754 · Received April 17, 2013

    Report

    Report Number
    3007566237-2013-01317
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    March 20, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATHETER ISSUE MIGHT HAVE BEEN PRESENT PRIOR TO THE CATHETER BEING REPLACED. ADDITIONAL INFORMATION WAS REQUESTED AND IT WAS REPORTED THAT THE PATIENT HAD A CHANGE IN THEIR SPASTICITY LEVEL AND THE EXACT LOCATION OF THE ISSUE WITHIN THE CATHETER WAS NOT KNOWN. THE CATHETER WAS REPLACED ON (B)(6) 2012. THE PATIENT'S CURRENT STATUS WAS NOT KNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166284 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention