BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3972894 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13803
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8784, SERIAL# (B)(4) IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. PRODUCT ID: 8782 SERIAL# (B)(4), IMPLANTED: (B)(4) 2013, PRODUCT TYPE; CATHETER. F(B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO ANOMALY. INTERROGATION OF THE DEVICE REVEALED IT WAS DELIVERING PRESERVATIVE FREE NORMAL SALINE UPON IT BEING RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT EXPERIENCED A PAINFUL PUMP SITE, WHICH WAS OF MILD SEVERITY. EXAMINATION RESULTS WERE ABNORMAL, REVEALING PAIN AT THE PUMP SITE AND SURROUNDING AREA. THE PUMP WAS NOT INFECTED, JUST PAINFUL FOR THE PATIENT. THE PATIENT REQUESTED REMOVAL. ON (B)(6) 2014, THE PUMP WAS EXPLANTED AND WAS NOT REPLACED. THE PUMP WAS NOT BEING USED TO INFUSE BACLOFEN OR MORPHINE SULFATE. AS OF (B)(6) 2014, THE EVENT WAS UNRESOLVED AND NO FURTHER ACTIONS WERE PLANNED. THE DRUG IN THE PUMP WAS UNKNOWN. IT WAS FURTHER REPORTED THAT THE PAIN WAS NOT RELATED TO THE DEVICE, AND THAT IT WAS UNKNOWN IF IT WAS RELATED TO THE PROCEDURE. THE PUMP WAS BEING USED TO DELIVER SUFENTA AND BUPIVACAINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WANTED THE PUMP REMOVED BECAUSE IT DID NOT MEET THE EXPECTATION OF PAIN CONTROL AND THE PATIENT WAS UNSATISFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450637 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention