BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRATHECAL CATHETER

    MDR report key: 11015042 · Received December 15, 2020

    Report

    Report Number
    3010079947-2020-00344
    Event Type
    Death
    Date Received
    December 15, 2020
    Date of Event
    September 24, 2020
    Report Date
    November 17, 2020
    Manufacturer
    FLOWONIX MEDICAL, INC.
    Product Code
    LKK
    UDI-DI
    00810335020099
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ADDITIONAL FOLLOW-UP FROM THE PATIENT'S DAUGHTER. PATIENT'S DAUGHTER STATED THAT THEY DO NOT HAVE DIRECT PHONE NUMBER OR EMAIL FOR THE PHYSICIAN. THEY REPORTED THAT THEY WERE AWAITING THE PATIENT'S ENTIRE MEDICAL FILE AND WOULD CONTACT FLOWONIX UPON RECEIPT. ADDITIONALLY, PATIENT'S DAUGHTER STATED, "I TALKED TO MY STEP FATHER ABOUT MY CONVERSATION WITH YOU AND HE SAID THAT I'M NOT REMEMBERING CORRECTLY, HE SAID THE DOCTOR WAS REFERRING TO [THE PATIENT'S] WOUNDS NOT HEALING BECAUSE OF [THEIR] MALNUTRITION. HE DOESN'T AGREE THAT DOCTOR [INITIALLY REPORTED] IS THE DOCTOR THAT ACTUALLY TOOK THE PAIN PUMP OUT EITHER." A SUPPLEMENTAL MDR WILL BE SUBMITTED IF/WHEN NEW INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    DIRECTOR OF POST MARKET SURVEILLANCE ATTEMPTED TO FOLLOW UP WITH THE EXPLANTING PHYSICIAN REGARDING THE ALLEGATION OF THE CATHETER NOT BEING SEALED AND ADDITIONAL DETAILS, BUT WAS UNSUCCESSFUL IN MAKING CONTACT. DIRECTOR OF POST MARKET SURVEILLANCE CONTACTED THE REPRESENTATIVE FOR THE AREA AND THEY STATED THAT THEY DIDN'T HAVE ANY FURTHER INFORMATION ON THIS PATIENT EXCEPT THAT THEY DID ASSIST A DIFFERENT PHYSICIAN WITH TURNING OFF THE PUMP 'A FEW MONTHS AGO' OVER THE PHONE. THIS PHYSICIAN WAS NOT THE PATIENT'S PRIMARY PHYSICIAN AND THE REPRESENTATIVE BELIEVES THE PATIENT'S HUSBAND HAD REACHED OUT TO THE PHYSICIAN AS THEY NEEDED A PAIN MANAGEMENT PHYSICIAN IN THE AREA. THE PUMP HAD ALLEGEDLY BEEN EMPTIED OF MEDICATION PREVIOUSLY, BUT REPRESENTATIVE DID NOT HAVE MORE INFORMATION. REPRESENTATIVE ALSO STATED THAT AN MRI WAS ORDERED FOLLOWING THE PUMP BEING TURNED OFF, BUT DIDN'T HAVE MORE INFORMATION. THERE IS NO FURTHER INFORMATION AVAILABLE POSSIBLE TO OBTAIN AS REPRESENTATIVE DID NOT WORK DIRECTLY WITH THE PATIENT OR EITHER PHYSICIAN THAT TOOK CARE OF THE PATIENT AT THE HOSPITAL THE PATIENT WAS TREATED AT. REPRESENTATIVE WAS NOT MADE AWARE OF THE EXPLANT WHEN IT OCCURRED. THE CAUSE OF THE REPORTED EVENTS CANNOT BE CONFIRMED OR DETERMINED. A SUPPLEMENTAL MDR WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD, WHICH INCLUDES VERIFICATION OF ALL STEPS IN THE MANUFACTURING OF THE US CATHETER KIT, VERIFICATION OF ALL FINAL TESTING PERFORMED BY/ON THE US CATHETER KIT, AND PACKAGING FOR SUBJECT US CATHETER KIT WAS PERFORMED. THE REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, ISSUES OR CAPAS ASSOCIATED WITH US CATHETER KIT FUNCTION. INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    RECEIVED MW5097413 FDA THAT REPORTED: "COULDN'T WALK; IS CURRENTLY IN HOSPITAL BECAUSE OF THE SEVERE SIDE EFFECTS OF THIS MEDICATION INCLUDING BUT NOT LIMITED TO SEVERE HALLUCINATIONS, [THEY] ALREADY HAD TROUBLE EATING DUE TO ISSUES WITH [THEIR] ESOPHAGUS AND DEPRESSION HOWEVER BECAUSE OF THE MEDICINE [THEY] EXPERIENCED A COMPLETE LOSS OF APPETITE. [THEY] WOULD NOT EVEN DRINK. [THEY] ARE AT TIMES SEMI-CONSCIOUS. LOTS OF CONFUSION, IRRITABLE, AGGRESSIVE VERBALLY. ELEVATED TROPONIN. [THEY'VE] HAD TO HAVE SEVERAL BLOOD TRANSFUSIONS AND [THEY'VE] BEEN IN THE HOSPITAL FOR A MONTH WITH COMPLICATION AFTER COMPLICATION. THE PAIN PUMP WAS REMOVED BECAUSE IT WAS SUSPECTED THAT THAT'S WHAT WAS CAUSING THE HALLUCINATIONS. AS OF TODAY [THEY] STILL HAVE VERY BAD HALLUCINATIONS." DIRECTOR OF POST MARKET SURVEILLANCE FOLLOWED UP WITH CONTACT TO OBTAIN FURTHER INFORMATION. DURING FIRST FOLLOW-UP ATTEMPT, CONTACT (PATIENT'S DAUGHTER) INDICATED THAT THE PATIENT HAD PASSED AWAY. DIRECTOR OF POST MARKET SURVEILLANCE FOLLOWED UP WITH IMPLANTING PHYSICIAN'S OFFICE. HEALTH ADMIN COORDINATOR REPORTED THAT THE PATIENT WAS SEEN FOR FOLLOW-UP ~TWO WEEKS AFTER INITIAL IMPLANT SURGERY AND REPORTED 'CONTINUED IMPROVEMENT OF PAIN LEVELS, IN ADDITION TO NAUSEA AND LOSS OF APPETITE.' FOLLOWING THAT APPOINTMENT, THE PATIENT RELOCATED AND WAS NOT SEEN AT THE PRACTICE AGAIN. AT IMPLANT, THE MEDICATION IN THE PUMP WAS 'PRIALT'. DURING SECOND FOLLOW-UP ATTEMPT WITH THE PATIENT'S DAUGHTER, THEY REPORTED THAT THE DAY AFTER RELOCATING TO AN ALTERNATE STATE, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM. PATIENT'S DAUGHTER STATED THAT THE PATIENT WAS HAVING PSYCHOTIC EPISODES AND WAS NOT EATING. PATIENT'S APPETITE HAD STARTED TO PICK UP PRIOR TO THE PUMP IMPLANT, BUT AFTER THE PUMP IMPLANT, THE PATIENT, "SLOWLY STARTED GOING DOWNHILL TO THE POINT WHERE [THEY] WOULDN'T EAT OR WALK." PATIENT WAS, "HALLUCINATING, IRRITABLE AND AGITATED." PATIENT'S DAUGHTER STATED THAT THEY WERE THINKING THAT [THE PATIENT] WAS STILL IN PAIN. WHEN THE PATIENT ARRIVED AT THE ER, [THE PATIENT] WAS ALLEGEDLY IN, "BAD SHAPE, (B)(6) LBS AND BADLY MALNUTRITIONED." PATIENT'S DAUGHTER STATED THAT THE PHYSICIANS WERE TRYING TO FIGURE OUT WHAT MEDICATION WAS IN THE PUMP AS THEY, "SUSPECTED THAT ANY MEDICATION THAT WAS IN THE PUMP WAS MAKING [THE PATIENT] HALLUCINATE." PATIENT'S DAUGHTER STATED THAT THE PATIENT HAD NEVER HAD PSYCHOTIC EPISODES OR OUTBURST IN THE PAST, PRIOR TO THE PUMP. THE PHYSICIAN REPORTEDLY RECOMMENDED TAKING OUT THE PUMP AS THEY WERE WORRIED, "IT WOULD GET INFECTED. HAVE TO TAKE IT OUT RIGHT AWAY BECAUSE THAT WILL BE BETTER FOR [THE PATIENT]." THE PUMP WAS REPORTEDLY PROTRUDING THROUGH THE PATIENT'S SKIN. PER THE PATIENT, "WHEN [PHYSICIAN] OPENED [THE PATIENT] UP, FLUID RAN EVERYWHERE. SPINAL FLUID, INFECTION, SOME OF THE MEDICATION ALSO. THERE WAS A SAC WITH PUS AND IT WAS INFECTED. CATHETER HAD NEVER SEALED AND THAT WAS CAUSING THE LEAKAGE." FOLLOWING EXPLANT, THE PATIENT CONTINUED TO HAVE SYMPTOMS AND THE FEEDING TUBE, PLACED PRIOR TO THE PAIN PUMP, REMAINED IN PLACE. PATIENT PASSED AWAY ~ ONE MONTH AFTER EXPLANT OF THE PUMP. THIS MFR REPRESENTS THE CATHETER AND MFR 3010079947-2020-00343 REPRESENTS THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1473474 INTRATHECAL CATHETER INTRATHECAL CATHETER LKK FLOWONIX MEDICAL, INC. 11823 26684 00810335020099

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| H| R