BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3112505 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07667
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8780 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO ANOMALY. ANALYSIS OF THE CATHETER FOUND THAT THE SC CONNECTOR HAD A TEAR IN THE SEAL NEAR THE GUIDE RING. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INITIAL ANALYSIS RESULT OF THE CATHETER WAS CODED RELIABILITY NON-CONFORMANCE. THIS TEAR IN THE SILICONE SEAL ISSUE WAS FURTHER INVESTIGATED INTERNALLY AND CONCLUDED THAT THE CORRECT CODING SHOULD BE NO SIGNIFICANT ANOMALY AND/OR EXPLANT DAMAGE. ANALYSIS OF DEVICES WITH OBSERVED TEARS IN THE SEAL NEAR THE GUIDE RING DETERMINED THAT THE ANOMALY DOES NOT AFFECT DEVICE PERFORMANCE OR ITS ABILITY TO MEET PRODUCT SPECIFICATIONS. THE TEARS IN THE SEAL MATERIAL DO NOT AFFECT THE CONNECTOR PERFORMANCE AND THEY DO NOT PREVENT THE CONNECTION FROM REMAINING PATENT OR CREATE A LEAK CONDITION. IN ADDITION, THERE ARE NO ALLEGATIONS OF EMBOLISMS DUE TO TEAR. THESE TEARS IN THE SEAL ALSO DO NOT PRESENT A PERFORMANCE ISSUE TO THE CONNECTOR IF THE CATHETER IS RECONNECTED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: FURTHER ANALYSIS DETERMINED THAT THE TEAR IN THE SEAL NEAR THE GUIDE RING WAS NOT SIGNIFICANT TO THE CATHETER¿S IN-VIVO PERFORMANCE. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ALLERGIC REACTION/EROSION AND INFECTION/MENINGITIS. THE PATIENT WAS HOSPITALIZED AND THE DEVICE SYSTEM WAS EXPLANTED. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. IT WAS LATER REPORTED PER THE HCP THAT THE PATIENT WAS DOING WELL, ALERT AND AWAKE. SHE WAS ON A NURSING UNIT RECEIVING ANTIBIOTICS: CIPRO EVERY 12 HOURS AND CEFEPIME EVERY 8 HOURS SO SHE WAS NOT INFECTION-FREE AT THAT POINT. NO INFORMATION WAS AVAILABLE ON LENGTH OF TIME PATIENT WILL REMAIN ON ANTIBIOTICS. THE PATIENT WAS ON ORAL BACLOFEN 30 MG 3X/DAY. SHE WAS CURRENTLY AFEBRILE AND GETTING FEEDS THROUGH A G-TUBE. NO OTHER DETAILS AVAILABLE AT THIS TIME. THE EXPLANTED PUMP AND CATHETER WERE SENT IN TODAY. IT WAS LATER REPORTED THAT THE ORGANISM WAS ENTEROCOCCUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212907 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R