BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4090347 · Received September 15, 2014

    Report

    Report Number
    3004209178-2014-17049
    Event Type
    Injury
    Date Received
    September 15, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS INDICATED THAT THE PATIENT EXPERIENCED REDNESS AND SWELLING WITH PUFFINESS AND FLUID AROUND THE POCKET OF THE PUMP. THE PATIENT¿S GRAM-STAIN WAS NEGATIVE, BUT HE EXHIBITED A MODERATE WHITE BLOOD CELL COUNT THAT WAS ELEVATED. THE DEVICE SYSTEM WAS REMOVED DUE TO THE SUSPECTED EARLY ONSET OF A POSSIBLE INFECTION AND THE PATIENT WAS PUT ON ANTIBIOTICS. IT WAS LATER REPORTED THAT CULTURES HAD BEEN TAKEN FROM THE DEVICE POCKET AND CEREBROSPINAL FLUID (CSF) AND STAPHYLOCOCCUS CAPITIS WAS CULTURED. IN ADDITION, AS THE STAPHYLOCOCCUS CAPITIS WAS CULTURED FROM THE CSF, THE PATIENT HAD BEEN DIAGNOSED WITH MENINGITIS. THE ONSET OR DIAGNOSIS OF THE INFECTION HAD BEEN APPROXIMATELY AUGUST (B)(6) 2014. IT WAS NOTED THAT PERIOPERATIVE ANTIBIOTICS HAD BEEN ADMINISTERED. FOLLOWING EXPLANT OF THE SYSTEM, THE PATIENT DEVELOPED ASPIRATION PNEUMONIA AND DRUG WITHDRAWAL SYMPTOMS INCLUDING A SEVERE WORSENING OF CENTRAL SPASTICITY. AT THE TIME OF REPORT, THE EVENT WAS CONSIDERED ONGOING. THE PATIENT WAS IN THE HOSPITAL RECEIVING A PRESCRIPTION FOR THE PNEUMONIA AND ORAL BACLOFEN. THE DEVICE SYSTEM HAD BEEN USED TO DELIVER BACLOFEN. THE OUTCOME OF THE EVENT HAD YET TO BE REPORTED. FURTHER FOLLOW-UP WAS BEING REQUESTED TO ASCERTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568962 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR Hospitalization| R