MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. PROMETRA II PAIN PUMP; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 37800

Device Problems Break (1069); Defective Component (2292)

Patient Problems Pain (1994); Foreign Body In Patient (2687); Swelling/ Edema (4577)

Event Date 02/04/2020

Event Type  Death  

Event Description

My husband was diagnosed with pancreatic cancer on (b)(6) 2020.Subsequently due to severe pain and high bp from pain highest range 195/210 and inability to eat.Resulting in a lengthy hospital stay the doctors decided that an intrathecal pain pump would help best.The surgery was (b)(6) 2020.A prometra flowonix pump was installed he seemed to stabilize his pain however shortly afterwards we had to keep returning to (b)(6) hospital (b)(6) dr (b)(6).A minimum of twice weekly he could go back every three days to have increased meds per afterwards there was several e.R.Visits more hospital stays.Finally they decided in (b)(6) 2020 to perform a nuclear test to check the device my husband had swelling at the incision in his back.The 1st surgery she tighten up the incision area on his back.Shortly after it was swelling again by this time my husband was tortured in pain they worried about pain med prescribing the nuclear test after 3 days of x-rays showed the device was not working.A date in early (b)(6) to remove the device was performed by dr.(b)(6) at (b)(6) hospital.During the surgery the device in his spine was being removed it broke on re-attempt it broke a 2nd time which she had to leave a piece of the medical device in his thecal sac, my husband suffered horrendous pain until the day of his death (b)(6) 2021.I have photos and hospital records that we were given.I attempted to get an attorney i had one (b)(6) law but soon after my husband died they dropped his case there was no money in the case.I then turned to hospital ms.(b)(6) at first they did investigation said health and safety department stated the pain pump was working.Lie why would a cancer patient have a device removed if it was working.I do not want anybody else to suffer from this device.

• Brand Name: PROMETRA II PAIN PUMP
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.
• MDR Report Key: 16241345
• MDR Text Key: 308155121
• Report Number: MW5114474
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 37800
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Other; Hospitalization; Life Threatening; Death
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White