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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problem Overheating of Device (1437)
Patient Problems Pain (1994); Burning Sensation (2146)
Event Date 09/09/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that patient reports heating at the battery site. She described it as burning. She is also not getting good pain relief. No known environmental/external/patient factors that may have led or contributed to the issue. Patient reported battery site is very painful at random times. Patient states it will randomly "burn" and feels hot to the touch. I asked if she has turned the system off and if so do symptoms disappear, she confirmed that after about 10 minutes of the system being off the symptoms will go away. Changed programming and will meet with patient and physician if needed.  confirmed with patient that if the system is off the burning sensation will go away but then her typical pain comes back. Patient has an appointment with pain management physician 9/20 at 2:30pm. Rep let her know they will be there to run an impedance check to see if there are any issues. Patient would turn system off but then turn back on due to chronic pain coming back.  rep had patient change programs and monitor heating to report back in the next few days.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12474416
MDR Text Key271473893
Report Number3004209178-2021-13862
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/27/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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