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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
Event Date 03/26/2021
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 who was implanted with an implantable neurostimulator (ins) on (b)(6) 2021. It was reported that patient recently had a scs implanted on (b)(6) 2021 with hopes as a last resort for some form of pain relief and has been extremely disappointed in the product has had zero benefit.  no device malfunction was reported. Additional information received from patient on (b)(6) 2021. Patient responded back from follow up sent and reported significant increase of lumbar pain now daily #8-9 constant, after scs implanted now for the first time have radiating pain to both legs and feet, decrease activity due to the increased pain level. There are no additional factors or explanation for the increase pain level only change was the scs was implanted. The steps that patient has taken and will continue to take are weekly meetings with a manufacturer representative to make scs adjustments and try different programming with the hopes they find something that will help. As to patient's knowledge the scs was last resource for pain relief, the scs as well as all previous surgeries, procedures seem to make issues worse after everyone. Issue has not been resolved. Patient's last meeting with rep was on (b)(6) 2021 and rep indicated they would try new programming and then they can discuss removal if lack of improvement. The patient noted on (b)(6) 2021 that the patient constantly has pain going down their legs and zero relief from the spinal cord stimulation. The patient noted that it affects everything including the patient's sleep, movement, activities, and a constant need to lay flat. The patient has had multiple meetings with a manufacturer representative to make weekly spinal cord stimulation adjustments and the surgeon is now scheduling a revision surgery of the spinal cord stimulation to try and resolve the issues. The lack of relief has not been resolved. The patient has had increased pain meds as a result.

 
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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 Key12053258
MDR Text Key266074957
Report Number3004209178-2021-09862
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 CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 06/23/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/23/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received06/21/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/17/2020
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: 06/23/2021 Patient Sequence Number: 1
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