BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2160934 · Received June 16, 2011

    Report

    Report Number
    3004209178-2011-04487
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 19, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE THAT WAS IMPLANTED WAS AN EXPIRED DEVICE. THE IMPLANT DATE WAS (B)(6) 2011. THE USE BEFORE DATE WAS(B)(6) 2011. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR UNKNOWN CONVERSION TYPE: MODEL 8590-9| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N27591005| CATHETER: MODEL 8709SC, LOT# N24591006| LOT# N213886| CATHETER: MODEL 8578, LOT# N204061014| EXPLANTED:| CATHETER: MODEL 8578, LOT# N204061014| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED: