BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1701039 · Received May 26, 2010

    Report

    Report Number
    3004209178-2010-04187
    Event Type
    Death
    Date Received
    May 26, 2010
    Date of Event
    April 23, 2010
    Report Date
    April 28, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    THE PUMP WAS IMPLANTED ON (B) (6) 2010; THE DOSAGE WAS SET TO 0.3 MG OF DILAUDID. ON (B) (6) 2010, THE DOSAGE WAS INCREASED TO 0.7 MG OF DILAUDID. THE PT WAS FOUND DECEASED THE NEXT DAY. THE HCP WAS UNSURE IF THE DEATH WAS RELATED TO THE IMPLANTED PUMP SYSTEM; NOTHING WAS DETERMINED AS OF THE DATE OF THE REPORT. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Death CATHETER: MODEL 8709SC, LOT#: N245101012.| EXPLANTED.| IMPLANTED.| IMPLANTED:| CATHETER: MODEL 8709SC, LOT#: N245101012| EXPLANTED: