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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 PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins). The reason for call was pt was calling for assistance to use his controller. Pt said his ins is charged to 90 percent but he noticed yesterday the level is not decreasing it has been at 90 percent for 3 days and his controller could not find his ins. Worked with pt to use the controller and after unlocking the controller found the device, pt turned stim on. Reviewed if stim was off for 3 days, that is why it stayed at 90 percent. Asked and pt said he did not turn stim off. Asked if pt had let his ins go dead and pt said no he had not. The patient mentioned unrelated medical history. Pt said he already had an mri. And a cat scan. Reviewed turning stim off for medical tests. Reviewed potential reasons and resolution information if the controller may not find the ins and offered online support information. Pt asked for manufacturing representative (rep) contact. Redirected to healthcare provider (hcp) to contact a rep. Patient called back the same day and stated that "the machine does not work at all". Pt stated the ins charge is at 70% and it has not moved. Pt stated that they did verify that the ins was on by pressing the power button on the controller. Instructed pt to increase stimulation. Pt confirmed that after increasing stimulation they did feel stimulation. The troubleshooting steps that were taken on the call resolved the issue. No symptoms were reported.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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 Key11373875
MDR Text Key233353846
Report Number3004209178-2021-03180
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 consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2021
Is this an Adverse Event Report? No
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 Received03/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/29/2020
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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