BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3241163 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12107
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF CATHETER SERIAL # (B)(4), REVEALED A DETACHED AND/OR MISSING COLLET FROM THE PIN CONNECTOR. THE CONNECTOR PIN WAS RETURNED IN TWO PIECES. AS RECEIVED, ONE OF THE COLLETS ON THE PIN CONNECTOR WAS DETACHED AND NOT RETURNED. INSPECTION OF THE BODY OF THE PIN CONNECTOR WHERE THE COLLET DETACHED FROM DID NOT SHOW ANY ANOMALIES. A ¿GOOD¿ COLLET WAS PLACED ON THE BODY OF THE PIN CONNECTOR AND THE DETENTS ON THAT PORTION OF THE PIN CONNECTOR RETURNED BY THE CUSTOMER SUCCESSFULLY HELD THE COLLET IN PLACE. ALSO, THERE WAS WHAT APPEARED TO BE A SLICE CUT IN THE PORTION OF THE CATHETER THAT WAS RETURNED WITH THE PIN CONNECTOR.

    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 THE CONNECTOR PIN WAS BROKEN WHEN THE HEALTHCARE PROVIDER WENT TO ATTACH IT TO THE SPINAL SEGMENT OF THE CATHETER. AS A RESULT, THE HEALTHCARE PROVIDER USED AN ACCESSORY KIT AND ATTACHED THE COLLET FROM THE KIT IN ORDER TO ATTACH THE CATHETER PIECES TOGETHER. THE CONNECTOR PIN WAS RETURNED TO THE MANUFACTURER. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THE EVENT. THE DEVICE SYSTEM HAD BEEN USED TO DELIVER DILAUDID, BUPIVACAINE AND CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340463 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR