BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3863866 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11275
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 20, 2014
    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
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THERE WAS A REVISION PLANNED FOR (B)(6) 2014. THE PATIENT WAS EXPERIENCING POCKET DISCOMFORT AND FELT THE PUMP MOVING AROUND/SLIDING DOWN IN THE POCKET. THE PATIENT ALSO HAD PAIN AT THE PUMP POCKET AND WANTED TO HAVE THE PUMP MOVED TO THE OTHER SIDE OF THEIR ABDOMINAL. THE CATHETER WAS REVISED ON (B)(6) 2014 TO ACCOMMODATE THE PUMP REPOSITIONING TO THE OPPOSITE ABDOMEN. A CATHETER WAS ADDED TO THE PATIENT'S PRE-EXISTING INTRATHECAL CATHETER. THE PUMP REQUIRED REPROGRAMMING AS A RESULT OF THE EVENT. THE PUMP WAS USED TO INFUSE MORPHINE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE PATIENT WAS SCHEDULED TO HAVE A NEW PUMP IMPLANTED BECAUSE HER CURRENT PUMP "DROPPED WAY LOW BECAUSE THERE WASN'T A POCKET MADE" DURING THE FIRST IMPLANT SURGERY. THE PATIENT WAS TOLD THAT THE IMPLANTING PROVIDER DID NOT MAKE A POCKET FOR THE PUMP AND THE SURGERY ONLY TOOK 20 MINUTES. THE PUMP DROPPING STARTED ABOUT A MONTH AFTER IMPLANT AND ABOUT 2 MONTHS AGO ¿DROPPED COMPLETELY¿ WHICH WAS PAINFUL. IT WAS LATER REPORTED THAT THEY HAVE TO REMOVE THE PUMP BECAUSE A POCKET WAS NOT MADE AND IT HAS FALLEN DOWN IN THE GROIN AREA. THE PATIENT WAS WONDERING IF THE PUMP WAS NOW MALFUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338866 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention