BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5219830 · Received November 12, 2015

    Report

    Report Number
    3004209178-2015-22677
    Event Type
    Injury
    Date Received
    November 12, 2015
    Report Date
    October 22, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8590-1, LOT # N242817, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER. THE RESULTS OF THE MRI PERFORMED DETERMINED THERE WAS NO GRANULOMA.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT CURRENTLY RECEIVING FENTANYL (12MG/ML; DOSE UNKNOWN BY REPORTER) AND BUPIVACAINE (10MG/ML; DOSE UNKNOWN BY REPORTER) VIA AN IMPLANTED PUMP. THE INDICATION FOR PUMP USE WAS NON-MALIGNANT PAIN AND OTHER CHRONIC/INTRACTABLE PAIN (TRUNK/LIMBS). IT WAS REPORTED THAT THE PATIENT HAD AN MRI ON (B)(6) 2015 TO RULE OUT A GRANULOMA. THE RESULTS OF THE MRI, DIAGNOSTICS PERFORMED, ACTIONS/INTERVENTIONS TAKEN, THE CAUSE OF THE EVENT, AND RESOLUTION OF THE EVENT WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750021 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Other