BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1150165 · Received September 3, 2008

    Report

    Report Number
    3004209178-2008-05398
    Event Type
    Death
    Date Received
    September 3, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 4, 2008
    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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DIED. THE CAUSE OF DEATH WAS UNK. IT WAS UNK IF THE DEATH WAS DEVICE RELATED. THE PT WAS SEPTIC WHEN HE ARRIVED AT THE HOSP. THE PT HAD MENINGITIS. THE HEALTH CARE PROFESSION (HCP) REPORTED THAT THE PT WAS SEEN TWICE FOLLOWING PUMP IMPLANT AND THE INCISION "LOOKED GREAT". THE PT WAS SEEN BY THE SURGEON SOMETIME IN 2008, AND IT WAS NOTED THAT THERE WAS SOME DRAINAGE COMING FROM THE INCISION SITE. THE HCP DID NOT FEEL THIS WAS ANYTHING TO WORRY ABOUT. A FEW DAYS LATER, THE PT WENT TO HIS MOTHER'S HOME AND SHE REPORTED THAT HE WAS INCOHERENT AND CALLED 911. THE PT WAS TAKEN TO THE ER WHERE HIS TEMP WAS 107 DEGREES. THE HCP WAS CONCERNED THAT WITH THE PT'S HISTORY OF DRUG PROBLEMS THAT HE MAY HAVE ACCESSED HIS PUMP. THE HCP WANTED THE PUMP EXPLANTED AND ANALYZED BUT ACCORDING TO THE HCP, THE PT'S MOTHER AND LAWYER HAD THE PUMP. IT WAS UNK IF AN AUTOPSY HAD BEEN PERFORMED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED.

    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 Death PROGRAMMER MODEL 8840| IMPLANTED| EXPLANTED| CATHETER MODEL 8709SC