BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 12351450 · Received August 20, 2021

    Report

    Report Number
    3010079947-2021-00245
    Event Type
    Death
    Date Received
    August 20, 2021
    Date of Event
    July 23, 2021
    Report Date
    July 23, 2021
    Manufacturer
    FLOWONIX MEDICAL, INC.
    Product Code
    LKK
    UDI-DI
    00810335020228
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER INTERNAL MEDICAL REVIEW, IT WAS STATED THAT WITHOUT MEDICAL RECORDS, IT IS IMPOSSIBLE TO KNOW THE CAUSE OF THE DEATH. IT IS UNLIKELY THAT THE INTRATHECAL PUMP AND CATHETER CONTRIBUTED TO THE DEATH, BUT THERE IS NOT ENOUGH INFORMATION TO RULE IT OUT. FOLLOW-UP ATTEMPTS TO OBTAIN THE PATIENT'S MEDICAL RECORDS WERE UNSUCCESSFUL, AND THEREFORE, NO FURTHER DETERMINATION CAN BE MADE AT THIS TIME. A SUPPLEMENTAL MDR WILL BE SUBMITTED IF FURTHER INFORMATION IS ABLE TO BE OBTAINED. INTERNAL COMPLAINT NUMBER: COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    PER FOLLOW-UP WITH CS, THE INFORMATION REGARDING THE NEUROSURGEON'S REPORT OF CATHETER POSITION CANNOT BE CONFIRMED OR CLARIFIED. WHEN ASKED ABOUT THE INITIAL IMPLANT SURGERY, CS REPORTED THAT THE PHYSICIAN REQUIRED A SECOND CATHETER AS THE INITIAL CATHETER REPORTEDLY HAD A BENT STYLET FOLLOWING DIFFICULTY ADVANCING. THE SECOND CATHETER WAS PLACED WITHOUT ISSUE, AND THE PHYSICIAN REPORTEDLY GOT BACK CSF. THE FIRST CATHETER WAS SHEARED OFF AND REMAINED IN THE INTRATHECAL SPACE. DEVICE WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD, WHICH INCLUDES VERIFICATION OF ALL STEPS IN THE MANUFACTURING OF THE PUMP, VERIFICATION OF ALL FINAL TESTING PERFORMED BY/ON THE PUMP, VERIFICATION OF STERILIZATION, AND PACKAGING FOR SUBJECT PUMP WAS PERFORMED. THE REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, ISSUES OR CAPAS ASSOCIATED WITH PUMP FUNCTION. PENDING INTERNAL MEDICAL REVIEW AND FOLLOW UP INFORMATION FROM THE PATIENT'S NEUROSURGEON. INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    CLINICAL SPECIALIST (CS) CONTACTED TECHNICAL SOLUTIONS TO REPORT THAT A PATIENT HAD EXPIRED. THE PATIENT WAS INITIALLY IMPLANTED DUE TO HAVING UNCONTROLLED PAIN. FOUR DAYS AFTER IMPLANT, THE PATIENT WAS BROUGHT TO THE ER WITH SYMPTOMS OF OVERSEDATION. CS GUIDED THE STAFF THROUGH SHUTTING OFF THE PUMP. CS REPORTED THAT THE PATIENT WAS TREATED FOR THEIR SYMPTOMS, BUT IS UNSURE OF HOW THEY WERE TREATED. THE PATIENT WAS REPORTEDLY PROVIDED WITH ORAL PAIN MEDICATION VIA PATCHES AND IV. THE PATIENT WAS THEN TRANSFERRED TO AN ALTERNATE HOSPITAL BECAUSE THE ORIGINAL HOSPITAL DID NOT HAVE A NEUROSURGEON ON STAFF. FOLLOWING THE TRANSFER, THE ORIGINAL/IMPLANTING PHYSICIAN VISITED THE PATIENT WHO WAS REPORTEDLY DOING WELL, AND SLEEPING. PHYSICIAN WAS ALSO INFORMED THAT THE PATIENT HAD BEEN GIVEN IV DILAUDID TO MANAGE PAIN. AT A LATER DATE, THE ORIGINAL/IMPLANTING PHYSICIAN WAS IN CLINIC AND WAS INFORMED THAT THE PATIENT HAD EXPIRED. THE PATIENT'S NEUROSURGEON INFORMED THE PHYSICIAN THAT THE PATIENT PASSED DUE TO AN ACID/BASE ISSUE. THE PATIENT WAS REPORTEDLY UNABLE TO PROPERLY EXPEL CARBON DIOXIDE, AND THE FINAL 'CAUSE OF DEATH DIAGNOSIS' WAS REPORTED TO BE ENCEPHALOPATHY. ADDITIONALLY, THE NEUROSURGEON REPORTED THAT THE CATHETER CONNECTED TO THE PUMP WAS IN THE SPINAL CORD RATHER THAN THE INTRATHECAL SPACE. FURTHER FOLLOW-UP INFORMATION IS PENDING TO CLARIFY THE MEANING OF THIS STATEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247185 PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC. 13827 27686 00810335020228

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R| D