BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2143049 · Received June 23, 2011

    Report

    Report Number
    3004209178-2011-04714
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    April 23, 2011
    Report Date
    May 27, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALARM HAD OCCURRED FOR A MOTOR STALL WHICH RECOVERED AS PER THE LOGS AND THE ALARM WAS OCCURRING AGAIN. ON (B)(6) 2011, IT WAS REPORTED BY THE HCP THAT THE PUMP LOGS SHOWED MOTOR STALL ON (B)(6) 2011 WITH NO RECOVERY. THE PT EXPERIENCED WITHDRAWAL ON (B)(6) 2011. PT ALSO HAD A HEART ATTACK A SHORT TIME LATER, BUT THEY WEREN'T SURE IF IT WAS RELATED. THE PUMP HAD BEEN SCHEDULED TO BE REPLACED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 8591, LOT# C16395| CATHETER: MODEL 8709SC, LOT# N141873001| IMPLANTED:| IMPLANTED: