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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 Problem Electromagnetic Interference (1194)
Patient Problems Sleep Dysfunction (2517); Ambulation Difficulties (2544); Paresthesia (4421); Increased Sensitivity (4538); Insufficient Information (4580)
Event Date 11/30/2020
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 patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that an issue occurred when the pt had an mri 2-3 weeks ago. Pt noted the reason for the mri was due to problems w/ his right knee and that only part of his body was in the mri machine. Pt reports that about 6 minutes into the mri, the pt experienced pulling and tingling around his ins site that required him to stop the mri early. Pt states his body was really sensitive after the mri, he had a hard time walking, couldn't sleep on the side of the ins, and felt "water rippling down his back constantly". Pt states these issues lasted for 18h before he started to feel better. Pt states he charged and turned his ins back on after these issues subsided. Reviewed mri guidelines with the pt. Pt confirmed that the ins was in mri-mode (he has full-body eligibility), and that the mri staff had a week to get the mri guidelines. Reviewed considerations with getting the ins checked. Pt requested a  manufacturing representative (rep) be notified to possibly schedule an appt. At the health care provider's (hcp) office. Pt noted seeing a rep in the past for reprogramming. The issue was not resolved through troubleshooting.
 
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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 Key11057578
MDR Text Key223637210
Report Number3004209178-2020-22450
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 consumer
Reporter Occupation
Type of Report Initial
Report Date 12/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2019
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 Received12/21/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/22/2018
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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