BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1660177 · Received April 14, 2010

    Report

    Report Number
    3004209178-2010-03020
    Event Type
    Death
    Date Received
    April 14, 2010
    Date of Event
    January 1, 2010
    Report Date
    March 22, 2010
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPIRED. IT WAS UNK IF THE DEATH WAS RELATED TO THE IMPLANTED DEVICE SYSTEM. THE PHYSICIAN STATED THAT THE PT'S DEATH MAY HAVE BEEN CANCER RELATED, BUT THIS WAS NOT CONFIRMED. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death CATHETER: MODEL 8709SC, LOT# N233890009| IMPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNK| EXPLANTED: