BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3100417 · Received May 8, 2013

    Report

    Report Number
    3004209178-2013-07393
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 10, 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 Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND. FINAL ANALYSIS OF THE RETURNED CATHETER SEGMENTS REVEALED CATHETER BODY HOLE OR TEAR CAUSED BY CATHETER CONNECTOR PIN.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8731 LOT# SERIAL# (B)(4), IMPLANTED: 2003 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    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 LATER REPORTED THAT THE CAUSE OF THE EVENT WAS A FRACTURED CATHETER. THIS WAS OBSERVED DURING SURGERY ON (B)(6) 2013. THE PATIENT RECOVERED WITHOUT SEQUELAE. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID AND BUPIVACAINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ARACHNOIDITIS - CATHETER LEAK. THE PUMP AND CATHETER WERE EXPLANTED. IT WAS LATER REPORTED THAT THE PATIENT WAS HAVING A LOSS OF PAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201661 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention