BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2874194 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-11859
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 14, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709 SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2011 , PRODUCT TYPE CATHETER: PRODUCT ID, 8709 SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE CATHETER: PRODUCT ID, 8590-1 N201184, IMPLANTED: 2010 (B)(6), EXPLANTED: 2011 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTED, THE PUMP WAS EXPLANTED DUE TO BACTERIAL SPINAL MENINGITIS. PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. IT WAS INDICATED REGARDING IF THE PATIENT HAD MENINGITIS: YES- PROBABLE. THE SIGNS AND SYMPTOMS WERE FEVER REDNESS AND SWELLING. IV OR ORAL ANTIBIOTICS WERE ADMINISTERED. THE PRIMARY LOCATION OF THE INFECTION WAS THE LUMBAR REGION. THE PATIENT HAD PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R