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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 Inappropriate/Inadequate Shock/Stimulation (1574); Human-Device Interface Problem (2949); Insufficient Information (3190); Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Electric Shock (2554); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/18/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient reported that the stimulator is not providing much relief and stopped helping within less than 3 months.The patient stated that they think the healthcare provider (hcp) ¿screwed up¿ where the stimulator was located during their initial surgery.They noted that their pain was down in their lower lumbar and the stimulator is up in their middle back area.The patient added that since then, they have had new tremendous pain in their middle back.They added that the hcp indicated the new pain was muscle related and not spinal, but the patient feels the hcp ¿screwed up.¿ the patient stated that they met with the manufacturing representative for reprogramming.They indicated that they also had spinal injections.The patient noted that their hcp will ¿go in there and burn the nerves¿ the week following the report.The patient also stated that starting sometime in 2019, they can get a lot of jolts during their sleep, depending on how they lay.They added it had a lot to do with turning up the stimulation when they needed more relief, which made a difference.The patient was to continue to follow-up with their healthcare provider.No further complications were reported or anticipated.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received.Patient reported the same information indicating ins hasn't worked since the day it was put in and that he believes the hcp messed up the muscles in his back during implant surgery, because the day after he was implanted last july he has had pain every day since in the area of the ins.Pt said he is having cervical, thoracic, and lumbar mris to check if hcp did mess up his muscles during surgery.Pt's reason for calling was to ask if he is full-body eligible as the mri facility told him to call and ask.Pt attempted mri mode, but ins was not charged so pt was going to charge ins and then check mri mode (pss reviewed what full-body eligible icon looks like).Pss also recommended mri facility call or visit website for mri guidelines.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was reported that there was a procedure issue.The patient was experiencing extreme constant pain at their implant site since the procedure.The patient believes due to the surgeon fault with muscles at the site.The patient has had the unit programmed to three different areas for relief and unfortunately no relief was provided to any location.No further information was reported.
 
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Brand Name
INTELLIS
Type of Device
STIMULATOR, 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
MDR Report Key10115576
MDR Text Key193727108
Report Number3004209178-2020-09653
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00643169781702
UDI-Public00643169781702
Combination Product (y/n)N
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/14/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Date Manufacturer Received12/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age68 YR
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