BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1192076 · Received October 7, 2008

    Report

    Report Number
    2182207-2008-06389
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 11, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP AND SUTURELESS CONNECTOR HAVE BEEN RETURNED TO THE MFR FOR ANALYSIS, WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    APPROX 14 DAYS AFTER IMPLANT, THE PT'S STAPLES WERE DRAINING. THE HCP REPORTED, THE PT HAD AN INFECTION. THE PUMP WAS EXPLANTED. THE PT RECOVERED WITHOUT SEQUELA. THE PUMP WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER MODEL 8840 LOT# UNK| EXPLANATED| EXPLANTED| IMPLANTED| CATHETER MODEL 8703W LOT # L35607| CATHETER MODEL 8596SC LOT# N129890020| IMPLANTED