BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 3050863 · Received April 10, 2013

    Report

    Report Number
    3007566237-2013-01200
    Event Type
    Death
    Date Received
    April 10, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL LATER REPORTED THAT THE CASE WAS STILL PENDING; HOWEVER, THE INQUIRY OF THE DEVICE DEMONSTRATED THAT IT WAS WORKING PROPERLY WITH NO ALARMS OR ALERTS. FURTHER INFORMATION WAS TO BE PROVIDED WHEN THE CAUSE AND MANNER OF DEATH WERE KNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEALTH CARE PROVIDER WAS TRYING TO DETERMINE IF THE PUMP HAD FAILED. THE MEDICATION THIS DEVICE SYSTEM DELIVERED WAS NOT PROVIDED. THE REPORTED HAD PROVIDED LIMITED INFORMATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS PREVIOUSLY REPORTED IN MANUFACTURER¿S REPORT #3004209178-2013-06265 THAT [THE PATIENT HAD EXPIRED; THE CAUSE OF DEATH WAS UNDER INVESTIGATION. PATIENT DIED AT A GROUP HOME. IT WAS UNKNOWN IF THE PATIENT¿S DEATH WAS DEVICE RELATED. THE MEDICAL EXAMINER WANTED TO CHECK THE DEVICE TO SEE IF IT WAS STILL FUNCTIONING AND HAD DRUG. THE DEVICE SYSTEM WAS USED TO INFUSE BACLOFEN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DIED ON (B)(6) 2013 FROM COMPLICATIONS OF CEREBRAL PALSY. THE PATIENT HAD LIORESAL 2000 MCG/ML AT 200MCG/DAY. THE CAUSE OF DEATH WAS NOT DEVICE RELATED, AND THE REPORTER WAS UNSURE IF THE PUMP WOULD BE RETURNED.] A MEDICAL EXAMINER LATER REPORTED THAT THE CAUSE OF DEATH WAS NON-ATHEROMATOUS CORONARY ARTERY DISEASE, AND THE MANNER OF DEATH WAS ¿NATURAL.¿ THE PUMP WAS INTERROGATED AND FOUND TO BE FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153652 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Death