BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2884064 · Received December 21, 2012

    Report

    Report Number
    3004209178-2012-12188
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    November 23, 2012
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE CATHETER.

    Additional Manufacturer Narrative · 1

    THE PREVIOUSLY REPORTED CONCLUSION CODE NO LONGER APPLIES TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS REVISED IN (B)(6) 2012. IT WAS INDICATED THAT THE PUMP WAS "PUSHING OUT OF THE PATIENTS STOMACH" DUE TO WEIGHT LOSS. IT WAS NOTED THAT THE PUMP WAS "BULGING OUT". THE PUMP WAS REPOSITIONED FROM THE LEFT SIDE TO THE RIGHT SIDE. THE PATIENT'S OUTCOME WAS NOT PROVIDED. ACCORDING TO THE MANUFACTURER DEVICE REGISTRY, THE DRUG DELIVERED VIA PUMP WAS MORPHINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S WEIGHT LOSS WAS NORMAL. THE PATIENT WAS PREVIOUSLY OVERWEIGHT AND AFTER WEIGHT LOSS THE PUMP DID NOT FIT AS IT HAD BEFORE BECAUSE OF THE LOSS OF TISSUE AND FAT TO SUPPORT THE PUMP IN THAT AREA. THE PATIENT RECOVERED 'AS EXPECTED' WITHOUT ISSUE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THAT SINCE THE PATIENT LOST WEIGHT, AND "THEY HAD TO MOVE THE PUMP 2 OR 3 TIMES" THE PATIENT HAD IT IN THE FRONT AND THEN IT WAS KIND OF PROTRUDING. THE HCP SAID IT WAS GOING TO PUNCTURE THE PATIENT'S SKIN IF THEY LOST ANY MORE WEIGHT SO THEY MOVED IT TO THE RIGHT SIDE AND THE PATIENT GUESSED THAT DIDN'T WORK EITHER, THERE WAS A PROBLEM WITH THAT. THE PATIENT THEN HAD HIP SURGERY ON THEIR RIGHT SIDE SO THEY MOVED IT FROM THE RIGHT FRONT TO THE RIGHT BACK A WEEK AFTER HIP SURGERY. THE PATIENT THOUGHT IT WAS AT THE TIME OF THEIR HIP SURGERY AND THAT WAS 3 YEARS AGO. THE PUMP WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention