BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1844846 · Received September 23, 2010

    Report

    Report Number
    3004209178-2010-07227
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 25, 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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT THAT THE "DEVICE DOOR" FOR THE PUMP WAS OPENED, AS SEEN ON MRI. THE PT HAD DIARRHEA AND LOST FIFTY POUNDS. IT WAS ALSO STATED THAT THE PT HAD NO MEDICATION INFUSED FOR THE PREVIOUS EIGHT MONTHS AND EXPERIENCED WITHDRAWAL. THE PERSONAL THERAPY MANAGER (PTM) NEVER WORKED IN THE EIGHT MONTHS THE PT HAD IT. THE PT SUGGESTED THAT THE TRIAL PUMP HAD BEEN DEFECTIVE. THE PT HAD TYPE II DIABETES "WHICH CAUSED INFECTION." THE INFECTION WAS UNSPECIFIED AND IT WAS UNCLEAR IF THE INFECTION RELATED TO ANY OF THE STATED PT SYMPTOMS / OR EVENTS. THERE WAS NO INFO PROVIDED REGARDING THE TYPE, CONCENTRATION OR DOSAGE OF MEDICATION USED IN THE PT'S PUMP. NO FURTHER DETAILS OR PT OUTCOME WERE PROVIDED. ADDITIONAL INFO WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED 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 58 YR EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N200196008| IMPLANTED:| PROGRAMMER: MODEL 8835, LOT# UNK