BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3802899 · Received May 9, 2014

    Report

    Report Number
    3007566237-2014-01289
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT, THE PUMP WAS PUT IN A MESH POUCH AND SUTURED INTO PLACE. FIVE MONTHS AFTER IMPLANT THE PATIENT FELL. THE PUMP WENT OUT OF THE POCKET, BUT WAS KEPT IN PLACE WITH THE MESH POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280524 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR