BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2823316 · Received November 7, 2012

    Report

    Report Number
    3004209178-2012-10019
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 12, 2012
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6); CATHETER MODEL: 8598A, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING IMPLANT, PATIENT HAD EXPERIENCED A DEVICE POCKET/CATHETER TRACT INFECTION APPROX. IN MID-JULY. A SMALL HOLE WAS INDICATED TO HAVE BEEN DEVELOPED ON HER SKIN ALONG THE INCISION. PATIENT SYMPTOMS INCLUDED CELLULITIS, DRAINAGE, INCISIONAL WOUND OPENING AND PAIN. PATIENT WAS TREATED WITH MULTIPLE ROUNDS OF ANTIBIOTICS AND "STRUGGLED TO EVER GET THE INCISION TO COMPLETELY HEAL". IT WAS ADDED THAT PATIENT HAD A MEDICAL HISTORY OF CELLULITIS AND (B)(6). PATIENT WAS ADMITTED TO THE HOSPITAL AND INDICATED TO HAVE "HEMOGLOBIN OF 5". THE PUMP AND PARTIAL CATHETER WERE SURGICAL REMOVED AND DISCARDED. IN REGARDS TO THE CATHETER IT WAS ADDED THAT THE CATHETER WAS "CUT AND TIED OFF OUT OF THE RANGE OF THE POCKET INFECTION, CAPPED/ABANDONED/PARTIALLY REMOVED". DRUG DELIVERED VIA THE DEVICE WAS INFUMORPH. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R