BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2840677 · Received November 20, 2012

    Report

    Report Number
    3007566237-2012-02790
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    October 24, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8731SC, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNRELATED BACK "FUSION SURGERY" THE INDWELLING CATHETER WAS NICKED AT THE DISTAL SEGMENT. THE CATHETER WAS REVISED. THE HEALTHCARE PROVIDER (HCP) CUT THE SPINAL PORTION OF THE TWO PIECE CATHETER AND REPLACED THE DAMAGED PORTION; THE CATHETER WAS DISCARDED. HCP CHECKED FOR THE BACKFLOW OF CEREBROSPINAL FLUID AND PROGRAMMED THE PUMP TO PREVIOUSLY PROGRAMMED THERAPY. DRUG DELIVERED VIA THE DEVICE WAS INFUMORPH. IT WAS INDICATED THAT THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention