BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5528399 · Received March 27, 2016

    Report

    Report Number
    3004209178-2016-05440
    Event Type
    Injury
    Date Received
    March 27, 2016
    Date of Event
    July 1, 2015
    Report Date
    March 27, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCES THE MAIN COMPONENT OF THE DEVICE SYSTEM; THE OTHER RELEVANT COMPONENTS INCLUDE: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: CATHETER. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-9, LOT# N213886, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: ACCESSORY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO HAD BEEN RECEIVING 25% MORPHINE AND 10% DILAUDID VIA INTRATHECAL DRUG DELIVERY PUMP. THE INDICATIONS FOR USE OF THE PUMP WERE DEGENERATIVE DISC DISEASE AND NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED AN INFECTION AT THE PUMP POCKET SITE. THE PATIENT HAD GRADUALLY STARTED DEVELOPING SYMPTOMS IN (B)(6) 2015 THAT INCLUDED REDNESS, SWELLING, AND DRAINAGE/FLUID LEAKAGE AT THE SITE. THE PUMP SITE HAD BECOME REALLY RED, AND THE PUMP NEARLY PUSHED ITSELF THROUGH THE SKIN. IT WAS INDICATED THAT THE PATIENT WAS PLACED ON ORAL ANTIBIOTICS, AND BOTH THE PUMP AND CATHETER WERE REMOVED ON (B)(6) 2015. THE INFECTION SUBSEQUENTLY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184237 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