BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3140635 · Received May 31, 2013

    Report

    Report Number
    3004209178-2013-08486
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 8590-9, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY. (B)(4). ANALYSIS OF THE CATHETER FOUND DAMAGE HAD OCCURRED TO THE CATHETER BODY AND/OR GUIDEWUIRE DURING THE IMPLANT PROCEDURE. THE THREE SMALL PORTIONS OF THE CATHETER ALONG WITH THE COMPLETE GUIDEWIRE FOUND SEGMENT 1 HAD NO ANOMALIES, BUT SHEAR HOLES WERE FOUND IN SEGMENT 2 AND SEGMENT 3. THE GUIDEWIRE HAD TWO BENDS IN IT, 13 AND 58 CENTIMETERS (CM) FROM ITS DISTAL TIP. ANALYSIS OF THE REPAIR KIT (PRODUCT ID 8590-9) FOUND NO SIGNIFICANT ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE A CATHETER HAD MULTIPLE HOLES IN THE ONE PIECE CATHETER BETWEEN MARKINGS 51-60 CENTIMETERS (CM). THE DEFECTIVE CATHETER PORTION WAS IMPLANTED ON (B)(6) 2013 AND REMOVED ON (B)(6) 2013 AND THE CATHETER WAS SPLICED WITH A PIN CONNECTOR. IT WAS NOTED THAT THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT AND PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY/NO ADVERSE EVENT. FENTANYL WAS IN THE PUMP. IT WAS LATER REPORTED THAT BUPIVACAINE WAS ALSO IN THE PUMP. IT WAS NOTED THAT CATHETER WAS ON THE GUIDEWIRE FROM THE ACCESSORY KIT SO THE END WOULD NOT DAMAGE CATHETER TO BE ANALYZED. IT WAS INDICATED THAT THE CATHETER ON THE GUIDE WIRE WAS NOT PART OF THE PRODUCT ISSUE. THE CATHETER WAS PLACED AS USUAL. THERE WERE NO PROBLEMS REMOVING THE GUIDEWIRE AND NO RESISTANCE. ADDITIONAL INFORMATION RECEIVED REPORTS PATIENT OUTCOME AS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241318 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR