BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3841319 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09926
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8578, LOT# N139720, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    A PATIENT REPORTED THAT THEY WERE NOT ABLE TO FILL THE PUMP BECAUSE WHEN THEIR HEALTHCARE PROVIDER (HCP) READ THE PUMP ¿EVERYTHING CAME UP BLANK¿ AND ¿NOTHING WAS FILLED OUT OR PROGRAMMED¿. IT WAS ALSO NOTED THAT THE PATIENT¿S THERAPY WAS NOT WORKING AS EXPECTED. THE MEDICATION INFUSED WAS UNKNOWN. ON (B)(6) 2014 INFORMATION WAS RECEIVED FROM A PATIENT INDICATING THAT AS OF (B)(6) 2014 THE PUMP WAS STILL NOT WORKING, AND IT WAS ¿SHUT DOWN AND THE ALARM WAS ON¿. THEY WERE STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT THEY WERE WORKING WITH THEIR DOCTOR OR REPRESENTATIVE. THEY ALSO INDICATED THAT THEY HAD CONCERNS BUT HAD NOT SOUGHT FURTHER HELP. THE PATIENT INDICATED THEY HAD AN APPOINTMENT ON (B)(6) 2014 TO ¿REPLACE THE DEFAULT PUMP¿. THE PUMP WAS NOT PROGRAMMED WHEN SURGERY WAS REPORTEDLY PERFORMED ON (B)(6) 2014. ON (B)(6) 2014 THE DOCTOR¿S OFFICE TRIED TO PROGRAM WITH A REPRESENTATIVE. THE PATIENT¿S PRIOR PUMP HAD BEEN REMOVED AND REPLACED ON (B)(6) 2014, SO IT WAS UNCLEAR WHAT SURGERY WAS PERFORMED ON (B)(6) 2014. ON (B)(6) 2014 INFORMATION WAS RECEIVED FROM AN HCP INDICATING THAT THE MEDICATIONS INFUSED WERE PRESUMABLY THE ONES TRANSFERRED FROM THE PRIOR PUMP (DILAUDID, CLONIDINE, BACLOFEN, AND FENTANYL), BUT THERE WAS NO INFORMATION ON ELECTRONIC ANALYSIS. THE PATIENT WAS ON A FENTANYL PATCH AND DILAUDID. THE PATIENT REPORTEDLY DID NOT EXPERIENCE ANY SYMPTOMS AT THE TIME, AND THERE WAS NO CHANGE FROM BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319410 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention