BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1961522 · Received January 11, 2011

    Report

    Report Number
    3004209178-2011-00248
    Event Type
    Death
    Date Received
    January 11, 2011
    Date of Event
    November 16, 2010
    Report Date
    January 3, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PREVIOUSLY REPORTED PATIENT AND DEVICE CODES WILL BE UPDATED/CORRECTED TO THE FOLLOWING FOR THIS EVENT: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS PREVIOUSLY REPORTED IN MANUFACTURER REPORT # 3007566237-2013-02103. IT WAS LATER DETERMINED THAT IT WAS RELATED TO THIS EVENT. "IT WAS REPORTED THAT DURING A PUMP REFILL A COUPLE OF YEARS AGO, THE MEDICATION WAS PUT INTO THE WRONG PORT. THE PATIENT CODED IN THE OFFICE. THE PATIENT WAS IN THE ICU (INTENSIVE CARE UNIT) FOR A REALLY LONG TIME AND THEN WENT TO A NURSING HOME. HE WAS NEVER THE SAME. PRIOR TO THE EVENT, THE PATIENT ¿WENT ON TRIPS; STILLED MOWED HIS LAWN; STILL DID ALL OF THIS STUFF¿. THE PATIENT LIVED LESS THAN A YEAR BEFORE DYING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT."

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT ¿THE CALLER PROVIDED MORE MISINFORMATION THAN INFORMATION. THE PATIENT DID NOT DIE IN THE OFFICE AND NO FURTHER COMMENT COULD BE MADE¿. THE EVENT WAS CURRENTLY UNDERGOING LITIGATION.

    Description of Event or Problem · 1

    "LAWSUIT ALLEGES DEATH ASSOCIATED WITH A POCKET FILL WHICH CAUSED THE PT TO SUFFER AN OVERDOSE OF FENTANYL. THE CLAIMS ARE FOR FAILURE TO WARN PT AND PROPERLY INSTRUCT HEALTH CARE PROVIDER."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| H| L| R| S IMPLANTED:| CATHETER: MODEL 8703W, LOT#: L54371| EXPLANTED: