BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 2930287 · Received January 25, 2013

    Report

    Report Number
    3004209178-2013-00989
    Event Type
    Death
    Date Received
    January 25, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 2, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE INFUSION PUMP REVEALED THE FOLLOWING: THERE WERE NO ANOMALIES FOUND. FINAL DEVICE ANALYSIS OF THE CATHETER REVEALED THE FOLLOWING: THERE WAS A TEAR NOTED IN THE SEAL NEAR THE GUIDE RING.

    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

    THE INITIAL ANALYSIS RESULT OF THE CATHETER WAS CODED RELIABILITY NON-CONFORMANCE. THIS TEAR IN THE SILICONE SEAL ISSUE WAS FURTHER INVESTIGATED INTERNALLY AND CONCLUDED THAT THE CORRECT CODING SHOULD BE NO SIGNIFICANT ANOMALY AND/OR EXPLANT DAMAGE. ANALYSIS OF DEVICES WITH OBSERVED TEARS IN THE SEAL NEAR THE GUIDE RING DETERMINED THAT THE ANOMALY DOES NOT AFFECT DEVICE PERFORMANCE OR ITS ABILITY TO MEET PRODUCT SPECIFICATIONS. THE TEARS IN THE SEAL MATERIAL DO NOT AFFECT THE CONNECTOR PERFORMANCE AND THEY DO NOT PREVENT THE CONNECTION FROM REMAINING PATENT OR CREATE A LEAK CONDITION. IN ADDITION, THERE ARE NO ALLEGATIONS OF EMBOLISMS DUE TO TEAR. THESE TEARS IN THE SEAL ALSO DO NOT PRESENT A PERFORMANCE ISSUE TO THE CONNECTOR IF THE CATHETER IS RECONNECTED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CORONER'S OFFICE ASKED A MEDTRONIC NEUROMODULATION FIELD REPRESENTATIVE TO COME READ THE PUMP TO CONFIRM THAT THE PUMP DID NOT MALFUNCTION. THE PERSON AT THE CORONER'S OFFICE STATED THAT THE PATIENT DID NOT DIE OF AN OVERDOSE OR FROM THE PUMP. THE PATIENT'S SYMPTOMS AT THE TIME OF DEATH WERE UNKNOWN. IT WAS ADDITIONALLY REPORTED BY THE CORONER'S OFFICE THAT THEY DID NOT BELIEVE THE PATIENT RECEIVED AN OVERDOSE OF MORPHINE; THEY WOULD LIKE TO VERIFY THAT IT WAS FUNCTIONING PROPERLY. THE PUMP SYSTEM WAS BEING USED TO DELIVER INFUMORPH.

    Description of Event or Problem · 1

    A PATIENT DEATH WAS REPORTED. THE PATIENT WAS IMPLANTED ON (B)(6) 2012. EVERYTHING WAS NOTED TO HAVE GONE "FINE" DURING THE IMPLANT, AND THE PATIENT WAS NOTED TO HAVE BEEN FINE AFTER THE IMPLANT. IT WAS REPORTED THAT AT SOME POINT THE PHYSICIAN GAVE THE PATIENT A DOSE INCREASE. ON (B)(6) 2012 THE PHYSICIAN WAS NOTIFIED THAT THE PATIENT'S WIFE HAD FOUND THE PATIENT THE FOLLOWING MORNING DECEASED. IT WAS NOTED THAT THE PATIENT WAS "WEARING A PATCH WHICH HE SHOULD NOT HAVE BEEN USING WITH THE PUMP". THE PUMP WAS TO BE EVALUATED FOR POSSIBLE MALFUNCTION. AN AUTOPSY HAD BEEN PERFORMED BUT THE RESULTS WERE UNKNOWN. AS OF THE DATE OF THIS REPORT, THE CAUSE OF DEATH HAD NOT BEEN DETERMINED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35757 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Death