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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 Problems Migration or Expulsion of Device (1395); Energy Output Problem (1431); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)
Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Swelling/ Edema (4577)
Event Date 11/15/2021
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) for unknown indications for use.It was reported that on the left, one of the leads was still providing stimulation shooting to the head even though the stimulation was turned off; pt noted all 3 leads on the left and right were off but it was still hurting.Today the pt was driving to work and they got a really intense sensation shooting all the way up to the middle of the head so the pt turned the simulation off and the sensation was still there but not as bad.Ps reviewed role of rep and ps emailed local field representatives requesting them to contact the pt for further assistance.Pts hcp was dr.(b)(6).
 
Manufacturer Narrative
Continuation of d10: product id 97715 lot# serial# (b)(6) implanted: 2019-(b)(6) explanted: product type implantable neurostim ulator product id 3888-56 lot# va15jej serial# implanted: 2017(b)(6)explanted: product type lead product id 3888-56 lot# va15jej serial# implanted: 2017-(b)(6) explanted: product type lead product id 3777-60 lot# serial# (b)(6) implanted: 2017-(b)(6) explanted: product type lead product id 3888-56 lot# va1021z serial# implanted: 2016-(b)(6) explanted: product type lead product id 3888-56 lot# va1021z serial# implanted: 2016-(b)(6) explanted: product type lead product id 3777-60 lot# serial# (b)(6) implanted: 2016-(b)(6) explanted: product type lead 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 from the patient reporting that the cause of the leads still providing stimulation shooting to the head even though the stimulation was turned off and having intense sensation shooting all the way to the middle of their head was due to ¿their anchor had being bumped or something and they had moved the lead¿.They stated that the nerves around it were swollen still and the lead was still shooting to their head.They couldn¿t turn it up like they needed to.It was indicated that steps taken to address the issue was someone checked to make sure it was off and that the others were on and working.They were unable to do anything else.As of now, the patient could only turn it on low because it was still shooting.It was reported that they were waiting for the bump/swelling to go down, but their doctor thinks the only solution is to take all of the leads out and their batteries.They said they couldn¿t just go in and fix the one anchor.The patient stated that they couldn¿t live without their stimulators, their migraines would go back to 25/mth.There was no solution at the time.The issue was not resolved.The patient indicated that they were supposed to go back in in 2 to 3 weeks to see if the swelling went down.Then they¿d come up with a plan.The doctor gave them a steroid to see if it would help.The patient weighed 136 pounds at the time of the event.
 
Event Description
Additional information received from the consumer reported that the lead stopped providing the stimulation when it was off so it was fine.The issue had been resolved, though the patient noted they still had swelling around that anchor, but it was fine.
 
Manufacturer Narrative
Concomitant medical products: product id 97715 lot# serial# (b)(6) implanted: (b)(6) 2019 explanted: product type implantable neurostim ulator product id 3888-56 lot# va15jej serial# implanted: (b)(6) 2017 explanted: product type lead product id 3888-56 lot# va15jej serial# implanted: (b)(6) 2017 explanted: product type lead product id 3777-60 lot# serial# (b)(6) implanted: 2017-03-14 explanted: product type lead product id 3888-56 lot# va1021z serial# implanted: (b)(6) 2016 explanted: product type lead product id 3888-56 lot# va1021z serial# implanted: (b)(6) 2016 explanted: product type lead product id 3777-60 lot# serial# (b)(6) implanted: (b)(6) explanted: product type lead 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.
 
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Brand Name
INTELLIS
Type of Device
STIMULATOR, 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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12821659
MDR Text Key280835575
Report Number3004209178-2021-17108
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00643169781702
UDI-Public00643169781702
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 03/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/28/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Date Manufacturer Received02/18/2022
Date Device Manufactured11/06/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age40 YR
Patient SexFemale
Patient Weight62 KG
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