BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3132316 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08241
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 9, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4). FINAL ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND. FINAL ANALYSIS OF THE RETURNED CATHETER SEGMENT REVEALED SC CONNECTOR TEAR IN SEAL NEAR GUIDE RING.

    Additional Manufacturer Narrative · 1

    (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 OF THE SUTURELESS CONNECTOR WAS NOT SIGNIFICANT TO THE CATHETER¿S IN-VIVO PERFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2013. PER THE REPORTER, THE CAUSE OF DEATH WAS NOT DEVICE RELATED; THE PATIENT HAD BEEN ON HOSPICE CARE AND IT WAS BELIEVED THAT THE PUMP HAD BEEN TURNED OFF. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID.

    Description of Event or Problem · 1

    CORRECTED INFORMATION/ADDITIONAL INFORMATION: THE PATIENT DIED FROM MALIGNANT CANCER. THE PUMP HAD BEEN TURNED OFF. THERE WAS NOTHING WRONG WITH THE DEVICE; IT WAS THE CHOICE OF THE PATIENT TO HAVE IT TURNED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236488 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR