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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 Electromagnetic Interference (1194)
Patient Problems Abdominal Pain (1685); Undesired Nerve Stimulation (1980); Pain (1994); Insufficient Information (4580)
Event Date 06/03/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id 97715 lot# serial# (b)(4) implanted: (b)(6) 2019 explanted: product type implantable neurostim ulator. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that patient had an mri in a 3t tesla machine. According to the tech she did not inform her she had devices implanted - after procedure patient complained of stim feeling - she then told technician she had put unit on mri mode. The patient was sent to the er.   the patient did not notify the mri techs of the implant prior to the scan. The patient reported that the ins was turned off prior to the scan but did not have the patient remote to use to check the device following the scan. Following the scan the patient reported feeling odd. The caller stated that one lead up to the neck and another is in the lower back. The patient reported experiencing the following symptoms post mri scan to the mri techs: abdominal pain, right leg shin pain, the patient felt like stimulation turned on, and right side ear pain. The patient went to the er based on the radiologist recomm endation. Troubleshooting was not required. The issue was not resolved through troubleshooting.
 
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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 Key11940148
MDR Text Key267105868
Report Number3004209178-2021-08877
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 company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 06/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2019
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 Received06/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/03/2018
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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