BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3892193 · Received June 24, 2014

    Report

    Report Number
    3004209178-2014-11982
    Event Type
    Injury
    Date Received
    June 24, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALY, NORMAL DEVICE FUNCTION. A TEAR IN SEAL NEAR GUIDE RING IN THE CATHETER/SC CONNECTOR WAS OBSERVED DURING ANALYSIS, HOWEVER IT WAS CONCLUDED THAT THIS WAS A NON-SIGNIFICANT ANOMALY, ACCEPTABLE CATHETER TESTING. (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    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 REPORTED THAT THE PATIENT WAS SEEN FOR A DOSE ADJUSTMENT AND THE CLINICIAN FELT THAT THE WOUND AT THE PUMP POCKET LOOKED SUSPICIOUS; AN INFECTION WAS SUSPECTED. THE PATIENT WAS SENT FOR FURTHER EVALUATION AND ULTIMATELY ADMITTED AND EXPLANTED. THE DEVICE SYSTEM WAS DELIVERING BACLOFEN. IT WAS LATER REPORTED THAT THE PUMP WAS DELIVERING GABLOFEN. THE PUMP WAS LAST REFILLED AT IMPLANT. PERIOPERATIVE ANTIBIOTICS HAD BEEN ADMINISTERED. THE INFECTION WAS FIRST NOTICED BY THE PATIENT¿S PARENTS AROUND (B)(6) 2014. THEY MENTIONED IT AT THE PATIENT¿S PUMP RATE CHANGE APPOINTMENT ON (B)(6) 2014. THE PATIENT WAS ASSESSED BY THE NURSING STAFF AND THEN IMMEDIATELY REFERRED TO THE NEUROSURGERY OFFICE. THE PATIENT HAD SYMPTOMS OF REDNESS AND SWELLING. A CULTURE WAS OBTAINED AND PSEUDOMONAS AERUGINOSA WAS FOUND. A TOTAL DEVICE SYSTEM EXPLANT WAS DONE. THE PATIENT WAS TREATED WITH IV (INTRAVENOUS) ANTIBIOTICS AND ANTIBIOTICS WERE GIVEN VIA G-TUBE. AS OF (B)(4) 2014, THE PATIENT OUTCOME WAS REPORTED AS ¿ONGOING¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368409 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00014 YR Hospitalization| R