BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2832229 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10267
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8835 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID, 8590-1 LOT# N323952, IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2012 WITH 3 DAYS OF INCREASING HEADACHES AND "STIFF NECK". THE PATIENT WAS AFEBRILE. THE FOLLOWING DAY ON (B)(6) 2012, THE PATIENT WAS SEEN AGAIN IN THE ER. SHE HAD REMAINED AFEBRILE AND NO LONGER HAD A STIFF NECK; HOWEVER, THE HEADACHES WERE STILL PRESENT. THE PATIENT'S SYMPTOM ALSO INCLUDED INTRACTABLE PAIN AND WAS LOCATED AT THE DEVICE POCKET AND CATHETER TRACK. IT WAS REPORTED THAT THERE WAS LESS THAN 50% OF THERAPY RELIEF. THE PATIENT'S COMPLETE BLOOD COUNT (CBC) WAS NORMAL. THREE DAYS LATER, THE PATIENT WAS SEEN AT CLINIC AND THEN SENT TO THE ER FOR CONCERNS OF POSSIBLE MENINGITIS AND LOCAL SITE INFECTION OVER ABDOMINAL WALL. THE PATIENT'S WHITE BLOOD CELL (WBC) COUNT WAS (B)(6). OTHER RESULTS NOTED ON (B)(6) 2012, (B)(6). IT WAS ALSO NOTED ON THIS DATE, THAT THE INCISIONAL WOUND APPEARED "ERYTHEMA TOURS" WITH SOME SLIGHT DEHISCENCE OF THE WOUND AND PUS DRAINAGE. CULTURE WAS TAKEN FROM THE BLOOD AND THE DEVICE POCKET AND FUNGAL MENINGITIS WAS CONFIRMED. ANTIBIOTIC TREATMENT WAS NECESSARY AND THE PUMP AND CATHETER WAS EXPLANTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS ALIVE AND WITHOUT INJURY. THE DRUGS DELIVERED VIA PUMP WERE DILAUDID, BUPIVACAINE, AND CLONIDINE.

    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 00047 YR Hospitalization| R