BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1310535 · Received February 10, 2009

    Report

    Report Number
    3004209178-2009-00786
    Event Type
    Death
    Date Received
    February 10, 2009
    Date of Event
    January 11, 2009
    Report Date
    January 12, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE PATIENT'S PUMP WAS REPLACED DUE TO VOLUME DISCREPANCIES (SEE MANUFACTURER'S REPORT # 6000030-2009-00740). AT THE IMPLANT, THE CATHETER WAS ASPIRATED; THE PUMP WAS IMPLANTED; AND THE CATHETER WAS CONNECTED TO THE PUMP. THE STANDARD PRIME WAS CONDUCTED TO FILL THE DRUG PATHWAY. THE NEW PUMP WAS PLACED WITHOUT DIFFICULTY; THE ORIGINAL CATHETER WAS LEFT IN. THERE WAS NO DOCUMENTATION REGARDING THE EXACT CATHETER LENGTH. THE PHYSICIAN DID NOT WANT TO ESTIMATE A CATHETER LENGTH. BUT EVENTUALLY DID. HE ALSO DID NOT WANT TO DECREASE THE PATIENT'S DOSE, BUT BECAUSE THE PATIENT WASN'T GETTING DRUG FROM THE OLD PUMP, HE FINALLY DECIDED TO START HER AT 1.5 MG PER DAY. HE ALSO GAVE HER A 0.25MG BOLUS OVER 2 HOURS. THE PATIENT WAS RELEASED TO HOME WITHIN 3-4 HOURS AFTER SURGERY AND THE NURSES STATED THAT SHE WAS DOING FINE. THE PATIENT WAS FEELING SO GOOD THE NEXT DAY (SATURDAY) THAT SHE CANCELLED THE HOME HEALTH AIDE APPOINTMENT. THE PHYSICIAN INSISTED THAT THE HOME HEALTH AGENCY RESCHEDULE A VISIT ON SUNDAY. THE PATIENT ENDED UP BACK IN THE HOSPITAL ON SUNDAY, BUT WAS UNKNOWN WHAT SPECIFICALLY PRECIPITATED THE RETURN TO THE HOSPITAL OR HOW THE PATIENT WAS RETURNED TO THE HOSPITAL. THE PATIENT DIED AT THE HOSPITAL ON SUNDAY. IT WAS UNKNOWN IF AN AUTOPSY WOULD BE CONDUCTED, BUT THEY DID PLAN TO SEND THE PUMP BACK FOR ANALYSIS. ON INTERROGATION, THE PUMP LOGS SHOWED THE PUMP WAS USED TO DELIVER "MOR~B"(10 MG/ML). THE PATIENT HAD STATED THE PUMP ONLY DELIVERED MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| H CATHETER: MODEL 8709| EXPLANTED:| PROGRAMMER: MODEL 8840