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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHRO MED II INFUSION SYSTEM; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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MEDTRONIC NEUROMODULATION SYNCHRO MED II INFUSION SYSTEM; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8709 8637-20
Device Problem Obstruction of Flow (2423)
Patient Problems Emotional Changes (1831); Pain (1994); Suicidal Ideation (4429)
Event Date 08/13/2021
Event Type  Injury  
Event Description
Severe withdrawal after having my medtronic pain pump replaced on (b)(6) 2021.I have had a medtronic pain pump since 2008.I'm on my 3rd pump.After surgery on (b)(6) 2021 i got deathly ill.On (b)(6) 2021 went to the er on (b)(6) 2021 was diagnosed with withdrawal from new malfunctioning pain pump.I followed up the next morning with the dr who manages the pump.The pump was checked and found to be working.He used a c-arm to see if the catheter had come disconnected.I have a diagnosis of blocked medtronic pain pump catheter and have been scheduled for surgery 3 times; twice the neurosurgeon has canceled as i arrived for surgery and once less than 24 hrs before.I have been in severe pain, it has affected my mental health and i was at the point of killing myself, everything "medtronic has said this is an emergency" but the drs have not treated it as such.I'm hopeless at this point knowing the drs are doing nothing.I haven't ever had suicidal thoughts until this complication.The only antidepressant i took prion to now was trazodone for sleep.I feel like the drs are just blowing me off.Wrong test was ordered then they ordered a second dye test that came back with the same results.I am about to the end of my rope and may decide to leave the "state" to seek treatment in another.
 
Event Description
Severe withdrawal after having my medtronic pain pump replaced on (b)(6) 2021.I have had a medtronic pain pump since 2008.I'm on my 3rd pump.After surgery on (b)(6) 2021 i got deathly ill.On (b)(6) 2021 went to the er on (b)(6) 2021 was diagnosed with withdrawal from new malfunctioning pain pump.I followed up the next morning with the dr who manages the pump.The pump was checked and found to be working.He used a c-arm to see if the catheter had come disconnected.I have a diagnosis of blocked medtronic pain pump catheter and have been scheduled for surgery 3 times; twice the neurosurgeon has canceled as i arrived for surgery and once less than 24 hrs before.I have been in severe pain, it has affected my mental health and i was at the point of killing myself, everything "medtronic has said this is an emergency" but the drs have not treated it as such.I'm hopeless at this point knowing the drs are doing nothing.I haven't ever had suicidal thoughts until this complication.The only antidepressant i took prion to now was trazodone for sleep.I feel like the drs are just blowing me off.Wrong test was ordered then they ordered a second dye test that came back with the same results.I am about to the end of my rope and may decide to leave the "state" to seek treatment in another.
 
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Brand Name
SYNCHRO MED II INFUSION SYSTEM
Type of Device
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
MDR Report Key13578767
MDR Text Key285951442
Report NumberMW5107589
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model Number8709 8637-20
Was Device Available for Evaluation? No
Patient Sequence Number1
Treatment
CARISOPRODOL 350 MG PRN ; CBD CREAM ; CBD TINCTURE; HYDROMORPHONE 4 MG 1 - 4 X A DAY; IBUPROFEN 800 MG 2/DAY; LEXAPRO 10 MG/DAY; PROZAC ER 50 MG 1/DAY; TRAZODONE 50 MG/DAY; XANAX 1 MG 1-1/2 DAILY
Patient Outcome(s) Other;
Patient Age62 YR
Patient SexFemale
Patient Weight62 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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