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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 97716
Device Problems Electromagnetic Interference (1194); Energy Output Problem (1431); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2021
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 who was implanted with an implantable neurostimulator (ins). It was reported that for the last week or so, they had been getting the settings not available screen. The patient mentioned that it had happened a few times over the last week and it would clear but it won't clear now. The patient said it will not allow them to go to the intensity setting that they want (the patient said they tried raising intensities in other groups and got the same settings not available screen). The patient spoke with their manufacturer representative (rep) (b)(4) (last name asked, unknown) yesterday and this morning who redirected the patient to patient services. When asked if they had any traumas, falls, or any other medical tests or procedures, the patient said they had an mri yesterday. The patient said their ins is charged up and they had tried leaving the battery out of the controller for 3 hours yesterday. Patient services redirected the patient back to their rep to have their ins checked. 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 Key11642701
MDR Text Key245126567
Report Number3004209178-2021-05788
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 04/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2020
Device Model Number97716
Device Catalogue Number97716
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/13/2019
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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