BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3182602 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10713
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    December 1, 2011
    Report Date
    December 1, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: ADDED PRODUCT ID: NEU_UNKNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: CATHETER: MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DRUG IN THE PUMP WAS BACLOFEN. THE CAUSE OF THE EVENT WAS REPORTED TO BE DUE TO THE PRO GRAMMER AND A PUMP MOTOR STALL WITH RECOVERY WAS ALSO NOTED. THE PUMP WAS STALLED FOR ONE DAY AND THE CAUSE OF THE STALL WAS UNKNOWN. THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE HCP THAT FILLED THE PUMP THAT DAY HAD NEVER DONE IT BEFORE. THE HCP TRIED PUSHING THE MEDICATION IN TOO FAST AND IT LOCKED UP THE PUMP RESERVOIR PORT. THE HCP WAS THEN WALKED THROUGH WHAT TO DO AND IT WAS NOTED EVERYTHING WAS RESOLVED THAT SAME DAY. IT WAS STATED THERE WAS NEVER A PROBLEM WITH THE PUMP, ¿IT WAS A USER ERROR¿. IT WAS NOTED THAT THE PATIENT WAS FINE AND NO ISSUES WERE NOTED. THE EXACT DATE COULD NOT BE PROVIDED, BUT THAT IT WAS IN 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT 2 YEARS AGO RIGHT BEFORE CHRISTMAS, DUE TO INSURANCE ISSUES, PATIENT COULDN¿T GET HER PUMP REFILLED. DRUG DELIVERED VIA THE DEVICE WAS BACLOFEN. HER PUMP SHUT DOWN BECAUSE THE PUMP HAD GOTTEN SO CRITICALLY LOW THAT WHEN SHE WENT TO GET IT REFILLED, IT WOULDN¿T TAKE THE NEW MEDICATION. SHE WENT THE ENTIRE CHRISTMAS WEEKEND WITHOUT MEDICATION AND ¿THAT WAS TORTURE¿. THE PATIENT STATED HER DOCTOR HAD THE MANUFACTURER REPRESENTATIVE ASSIST, AND THEY WERE ABLE TO GET THE PUMP FILLED. 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
    282596 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR