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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 Electromagnetic Interference (1194); Overheating of Device (1437)
Patient Problem Burning Sensation (2146)
Event Date 03/10/2021
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 via manufacturer representative who was implanted with an implantable neurostimulator (ins) for spinal pain. It was reported that caller was with the pt today and notes that 6-7 months ago, the pt had an mri where the pt felt heating at the pocket site. The issue was only during the mri and did not persist after. The caller confirmed the pt is full body elig. The caller states he checked system today and impedances look fine, everything seems to be okay and there does not appear to be any long term complaints from the pt. Technical services reviewed mri labeling from page 20: "heating may be felt at the neurostimulator site during the mri scan. If the heating causes the patient discomfort, stop the mri scan immediately. ".
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12601821
MDR Text Key279906356
Report Number3004209178-2021-15115
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2020
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Date Manufacturer Received11/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/12/2019
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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