BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3761656 · Received April 21, 2014

    Report

    Report Number
    3004209178-2014-07589
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 27, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW INDICATED THAT THE CATHETER FOR THIS EVENT WAS PART OF AN IDE STUDY AND THE INFORMATION REGARDING THE CATHETER IS BEING REPORTED VIA THE CLINICAL STUDY; THEREFORE, THE CATHETER PATIENT/DEVICE CODES ARE NOT APPLICABLE FOR THIS EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN SICK SINCE (B)(6) 2014 WITH MULTIPLE SYMPTOMS, INCLUDING: ¿O2 SATURATIONS IN THE 70S, INCREASED HEART RATE, NO APPETITE, LETHARGIC, LOW GRADE FEVER, CHILLS, AND LOW BLOOD PRESSURE.¿ PATIENT HAD BEEN SENT THE EMERGENCY ROOM (ER). IT WAS NOTED THAT PATIENT WAS STILL IN THE HOSPITAL ON DAY OF REPORT. THEY WERE NOT AWARE OF WHAT SPECIFICALLY WAS GOING ON. THE PATIENT WAS ADMITTED WITH THE DIAGNOSIS OF HYPOXEMIA. IT WAS NOTED THAT THE PATIENT¿S DOSE WAS INCREASED THE DAY PRIOR TO THE ONSET OF SYMPTOMS ¿BY 2 NG/K/MIN.¿ IT WAS NOTED THAT THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2014. IT WAS NOTED THAT THE ¿ECG (ELECTROCARDIOGRAM), ECHO (ECHOCARDIOGRAM) AND CHEST X-RAY WERE ALL NORMAL FOR THE PATIENT.¿ ON (B)(6) 2014, THE PHYSICIAN DID ¿NOT THINK THERE WAS ANY RELATIONSHIP TO THE PUMP OR INVESTIGATION¿ HOWEVER WHEN THE FORM WAS RECEIVED, ¿UNKNOWN¿ WAS MARKED FOR SEVERAL OF THE DEVICE COMPONENTS. IT WAS NOTED THAT ON DAY OF REPORT, IN REVIEWING THE FORM, ALL COMPONENTS EXCEPT FOR THE CATHETER ASSESSMENT WERE UPDATED TO ¿NOT RELATED.¿ THE CATHETER REMAINED ¿UNKNOWN.¿

    Description of Event or Problem · 1

    REVIEW OF THIS MDR AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240417 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization