BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3902578 · Received June 30, 2014

    Report

    Report Number
    3007566237-2014-01822
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BUILDUP OF DRUG IN HIS PUMP POCKET. THE PATIENT CAME IN APPROXIMATELY 1 WEEK PRIOR TO A REFILL BECAUSE HE NOTICED WHAT LOOKED LIKE FLUID BUILDING UP AROUND THE PUMP POCKET. SOME OF THE FLUID WAS ASPIRATED AND TESTED AND THE PHYSICIAN SAID IT CAME BACK AS ¿MOSTLY MORPHINE¿. THE PHYSICIAN WANTED TO KNOW IF THE PATIENT¿S CATHETER WAS PART OF A FIELD ACTION; IT WAS UNCLEAR IF THE PHYSICIAN FELT THAT THE CATHETER WAS COMPROMISED. THE DEVICE SYSTEM WAS DELIVERING MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE CAUSE OF THE EVENT WAS THAT AN OCCLUDED CATHETER WAS SUSPECTED OR A PARTIALLY DISCONNECTED SUTURELESS CONNECTOR. FLUID WAS LEAKING BETWEEN THE PUMP AND THE CATHETER AT THE CONNECTION SITE. AS A RESULT, THE PUMP SEGMENT OF THE CATHETER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380540 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention