BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3192163 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-10950
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 2, 2008
    Report Date
    July 15, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1150-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO ANOMALY. ANALYSIS OF THE CATHETER SUTURE LESS CONNECTOR FOUND NON-SIGNIFICANT INDENT IN SEAL THAT DID NOT AFFECT INFUSION. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (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 HEALTHCARE PROVIDER (HCP) WAS NOT AWARE OF A MASS. THE DEVICE SYSTEM WAS ALSO USED TO DELIVER BUPIVICAINE 40MG/ML. IT WAS LATER REPORTED THAT THE DAILY DOSE WAS 3.894MG/DAY. IT WAS NOTED THAT NO SURGICAL INTERVENTIONS TOOK PLACE. THE PATIENT MERELY WANTED TO TAKE ORAL MEDICATIONS. NO HOSPITALIZATION WAS REQUIRED. THE PATIENT OUTCOME WAS REPORTED AS ¿NO INJURY

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STATED HER PUMP "NEVER WORKED" AND WAS NEVER EFFECTIVE WITH HER PAIN CONTROL. THE HCP DID NOT DO ANY TROUBLESHOOTING OVER THE SPAN OF THE DEVICE HISTORY TO DETERMINE THE CAUSE FOR THE LACK OF THERAPY. THE PATIENT HAD OTHER HEALTH ISSUES INCLUDING BEING ON OXYGEN AND BRUISING ALL OVER THE BODY. IT WAS NOTED, THE PATIENT WOULD NOT BE A SURGICAL CANDIDATE BECAUSE OF OTHER HEALTH ISSUES. THE PATIENT WAS TITRATED DOWN PRIOR TO TURNING PUMP OFF AND LAST FILL DATE WAS SET FOR (B)(6) BUT THEY DECIDED NOT TO FILL THE PUMP. HOWEVER, THE PUMP THEN STARTED TO BEEP EVERY HOUR AND THE PATIENT WAS BOTHERED BY IT SO THE PUMP WAS PROGRAMMED TO OFF STATE. IT WAS SUSPECTED THE PATIENT HAD A GRANULOMA. THE PUMP WAS USED TO DELIVER BUPIVACAINE AND DILAUDID 80MG/ML. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE SYSTEM WAS RETURNED WITH NO INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293630 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Other| R