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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); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Tingling (2171); Electric Shock (2554); Paresthesia (4421)
Event Date 07/29/2020
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 manufacturing representative (rep) and a patient.The patient reported that they had a shocking sensation during their mri on the day of the report.They stated that they were in the hospital for new numbness and tingling.The patient mentioned that they placed the implantable neurostimulator (ins) into mri mode.They noted that when the mri began, they started getting a tingling sensation in their leg, so the mri was stopped.They noted that the tingling went away when they sat up on the mri table.The patient stated that their remote was still in mri mode at the end of the mri, and they were able to turn the ins back on with no issues.The issue was resolved at the time of the report.
 
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 from a healthcare provider on february 5, 2021.They reported that on (b)(6) 2020, two hcps had verified that the implanted neurostimulator (ins) had been put into mri mode and had shown head-only eligibility prior to having the brain scan with a transmit/receive head coil.About a minute into the mri scan the patient had reported they felt stimulation turn on.The scan was stopped and the patient was removed from the scanner and checked out; everything was reported to be fine.The hcp was inquiring if other cases like this had been reported.Technical services sent a request to medical affairs to provide information to the hcp.
 
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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 Key10348220
MDR Text Key201207785
Report Number3004209178-2020-13185
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 company representative,consum
Type of Report Initial,Followup
Report Date 02/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/14/2020
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/29/2020
Initial Date FDA Received07/30/2020
Supplement Dates Manufacturer Received02/05/2021
Supplement Dates FDA Received02/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age56 YR
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