BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1971594 · Received January 25, 2011

    Report

    Report Number
    3004209178-2011-00614
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    June 22, 2010
    Report Date
    January 18, 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
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT UNDERWENT SURGERY ON (B)(6) 2010: THE "CONNECTION HAD TO BE RE-DONE WITH NEW TUBING," AND "TUBING CAME OFF." THE PT HAD A "HEART ATTACK" ON (B)(6) 2010 AND WAS HOSPITALIZED. IT WAS UNCLEAR IF THE PUMP MEDICATION WAS ADJUSTED BECAUSE OF THE HEART ISSUE. ON (B)(6) 2010 THE PUMP WAS REFILLED. ON (B)(6) 2010, THE "PUMP WENT OUT," AND THE "PUMP QUIT" WHILE THE PT WAS AT HOME. THE PTM (PERSONAL THERAPY MANAGER) DISPLAY WAS NOT RESPONDING AND WAS BLANK WHEN POWERED UP. A NEW PUMP WAS "ORDERED" ON (B)(6) 2010 AND PER THE REPORTER, THE MEDTRONIC EMPLOYEE "GAVE ME NEW PUMP." IT WAS UNCLEAR IF THE PUMP ISSUE WAS RELATED TO THE PTM ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 8832, LOT# NJG004922N| CATHETER: MODEL CATHETER, LOT# UNK