BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2143051 · Received June 23, 2011

    Report

    Report Number
    3007566237-2011-04728
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 27, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WENT THROUGH WITHDRAWAL TWICE BECAUSE HER CATHETER WAS KINKED. THE PT SAID SHE WAS SCHEDULED FOR REPLACEMENT SURGERY ON (B)(6) 2011. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention CATHETER: MODEL 8709, LOT# N068941024| EXPLANTED: | IMPLANTED: | IMPLANTED:| CATHETER: MODEL 8709, LOT# N068941024| EXPLANTED: