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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION MEDTRONIC'S PAIN PUMP. PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC NEUROMODULATION MEDTRONIC'S PAIN PUMP. PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Dehydration (1807); Diarrhea (1811); Dyspnea (1816); Emotional Changes (1831); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Urinary Frequency (2275); Kidney Infection (4502); Skin Burning Sensation (4540)
Event Date 07/20/2020
Event Type  Injury  
Event Description
I had an adverse reaction to fentanyl, morphine, and bupivicaine from pain pump. My pain clinic failed recognize that this was a drug reaction and subsequently it took about 18 months to recognize the need to stop these drugs. This adverse reaction had me hospitalized at least 10 times with life threatening problems. Before the correct diagnosis doctors thought it was dysautonomia of some sort. I experienced breathing problems, wild fluctuations in high and low blood pressure, over 220 for the systolic and then it could drop to a point where the doctors worried about a heart attack. I had idiopathic infections with high white counts, mostly with the kidney infections. The illness was with cyclical bouts coming every 5 to 20 days. They could last 3 to 16 days. The symptoms started with a dumping of the colon and frequent urination. I would after the first symptoms have severe fatigue and would be slightly out of my mind in a odd sort of reverie. My skin would burn with tiny bee bites all over and at times i had severe agitation with it. I could only manage to get to the bathroom and try to drink water. By the time i needed a hospital i could be quite dehydrated. These bouts would eventually pass and would have a few days off until the next. Stopping the drugs stopped these cycles of illness but the withdrawal problems are still with me today. At times would come back indicating that i was diabetic. It was a horrible experience but hopefully i will get past it. I do worry that my brain is damaged by the pain drugs as i am still suffering some symptoms. Fentanyl was the main drug in my pain pump. The illness first started in (b)(6) 2020. My testing was all over the place when acutely ill. It would eventually normalize. No viruses were detected and was tested for many illnesses all negative. I was healthy with these weird symptoms. Fda safety report id # (b)(4).
 
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Brand NameMEDTRONIC'S PAIN PUMP.
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
MDR Report Key14788057
MDR Text Key294669753
Report NumberMW5110459
Device Sequence Number1
Product Code LKK
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model Number8637-40
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 06/22/2022 Patient Sequence Number: 1
Treatment
D3; LEVOTHYROXIN AND LIPITOR. PAIN PUMP HAS BEEN EMPTIED AND FILLED WITH SALINE.
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