BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3182916 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10722
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 24, 2013
    Report Date
    April 11, 2016
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATED PATIENT CODES, DEVICE CODES, AND EVAL CODE-CONCLUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING THE PUMP AND THE CATHETER REMOVED ON THE DATE OF THIS REPORT DUE TO THE PATIENT¿S COMFORT. THE PATIENT WAS VERY THIN AND THE PUMP WAS BULKY. THE PATIENT WOULD BUMP INTO THINGS WITH THE PUMP WHICH MADE IT UNCOMFORTABLE. THE PUMP WORKED ¿GREAT¿ FOR THE PATIENT, A CANCER SURVIVOR. IT WAS FURTHER REPORTED THAT AT THE TIME OF EXPLANT THE PUMP HAD SALINE. THE PATIENT STATUS AFTER EXPLANT WAS NOT KNOWN. NO PRODUCT PROBLEM REPORTED. IT WAS THEN REPORTED THAT THIS PATIENT, (B)(6), HAD COMPLAINED OF THEIR SKIN FEELING TAUT AFTER ¿DRANDAL¿. THE PATIENT EXPERIENCED BRUISING AND SKIN DISCOMFORT AROUND THE PUMP SITE. THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND THERE WERE NO PATIENT INJURIES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER INDICATED THE PUMP WAS PREVIOUSLY DELIVERING MORPHINE. THE INDICATION FOR USE WAS NON-MALIGNANT PAIN AND CHEST WALL. THE PATIENT NOTED THE REASON FOR THE PUMP IMPLANT WAS BECAUSE HE HAD PAIN AFTER HAVING HIS LEFT LUNG REMOVED BECAUSE OF LUNG CANCER. THE PATIENT HAD TO HAVE HIS PUMP REMOVED BECAUSE IT WAS PAINFUL FOR HIM. THE PATIENT WAS A SMALL GUY AND IT WAS PAINFUL FOR HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284013 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention