BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3562642 · Received January 8, 2014

    Report

    Report Number
    3004209178-2014-00372
    Event Type
    Injury
    Date Received
    January 8, 2014
    Report Date
    August 8, 2016
    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
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT# L69917, IMPLANTED: 1999 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. (PRODUCT ID: 8709, LOT# L69917, IMPLANTED: (B)(6) 1999, PRODUCT TYPE: CATHETER. NO LONGER APPLIES). THE CATHETER WAS RETURNED, AND ANALYSIS FOUND SC CONNECTOR/CORING-TEARS-CUTS IN SEAL/MEETS LEAK CRITERIA PER NDHF1162-113599. THE PUMP WAS RETURNED AND ANALYSIS FOUND NO SIGNIFICANT ANOMALIES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATHETER WAS PARTIALLY EXPLANTED. IT WAS NOTED THAT THERE WAS FLUID IN THE POCKET. IT WAS REPORTED THAT THE CATHETER TEAR COULD BE SEEN AT THE CONNECTOR. IT WAS NOTED THAT THE CATHETER HAD A BREAK AT THE PUMP CONNECTOR. IT WAS REPORTED THAT THE ACTIONS AS A RESULT OF THE EVENT WAS A REVISION. IT WAS NOTED THAT THE CATHETER WAS CUT WHERE YOU COULD SEE THE TEAR. IT WAS REPORTED THAT THE CATHETER WAS REPLACED WITH A NEW CONNECTOR. IT WAS NOTED THAT A DYE STUDY WAS PERFORMED. IT WAS REPORTED THAT THE ISSUE WAS RESOLVED. IT WAS NOTED THAT THE CAUSE OF PRODUCT ISSUE WAS A CATHETER TEAR. IT WAS REPORTED THAT THE PUMP WAS BEING USED TO INFUSE DILAUDID. IT WAS NOTED THAT THE PATIENT¿S PUMP WAS EXPLANTED. IT WAS REPORTED THAT THERE WAS NO ALLEGED PRODUCT ISSUE. IT WAS NOTED THAT THE PUMP WAS REPLACED. IT WAS REPORTED THAT THE PATIENT¿S ¿PUMP WAS CLOSE TO ELECTIVE REPLACEMENT INDICATOR (ERI)¿. IT WAS NOTED THAT THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS ALIVE ¿ NO INJURY. IT WAS REPORTED THAT THE PATIENT HAD FLU LIKE SYMPTOMS, ¿FELT SEEK¿. IT WAS NOTED THAT THE LOCATION OF ISSUE OR SYMPTOM WAS THE DEVICE POCKET. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12873 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention