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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 Energy Output Problem (1431)
Patient Problems Pain (1994); Inadequate Pain Relief (2388)
Event Date 06/01/2021
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a patient regarding an external device and a implantable neurostimulator (ins) for spinal pain. The reason for the call was that the controller was not working right. It was lighting up and "looked like it's working but doesn't do anything". The patient had been troubleshooting for over a month and met a representative in person who compared their use to a tablet, reset the device, and unpaired the device, all without resolving the issue. A replacement controller was requested. Additional information received from a representative. It was reported that the representative met with the patient and the patient's new controller allowed amplitude change but the patient did not feel the increase in intensity. However, when using the clinician tablet to increase, the patient could feel stimulation changes just fine. The patient was typically at. 1 amplitude and. 3 would be too much for them. When testing with the controller, they increased all the way to 5. 0 and the patient did not feel anything. Additional information was received. The manufacturer representative reported the cause of the issue was unknown. Additional information received from a manufacturer representative. It was reported that the patient's stimulator was implanted for addressing the patient's foot pain which the representative had been able to capture pretty easily. The patient was experiencing the same thing today in the clinic where the patient would feel increases in stimulation made by the tablet but would not feel increases in stimulation made by the controller. They were using single programs in a group. The patient was very sensitive to stimulation and used 0. 1, 0. 2 and 0. 3 depending on their pain needs with 0. 3 ma being the highest level of stimulation the patient used. When they made these increases, they were feeling stimulation and just wanted a small amount more (a click or two) to address the pain by using the controller. This is when the patient would realize that they were not feeling an increase in stimulation. The representative kept the pulse width and rate the s ame for all of the patient's programs(80us and 100hz) and adaptive stimulation was not enabled. The patient did not have any intermittency of stimulation or positional stimulation that made them increase stimulation to a really high level. The representative did not perform an impedance test since that could be uncomfortable for patient given their low level of stimulation. The patient was not seeing the "settings not available" message on their controller and no "out of regulations" notifications occurred on the tablet. The representative was going to send in the log files and an engineer would be consulted regarding the data. The representative also noted that they erased all the settings and this did not resolve the issue. No further complications reported.

 
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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 Key12378342
MDR Text Key268499198
Report Number3004209178-2021-13027
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
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 09/10/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/28/2021
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 Received08/27/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/08/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/27/2021 Patient Sequence Number: 1
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