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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 Overheating of Device (1437)
Patient Problems Pain (1994); Burning Sensation (2146); Sleep Dysfunction (2517)
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
It was reported that the last couple weeks when patient would recharge the stimulator they experienced dull pain going from implant down  spine almost down to the tail bone and the pain was almost like a tooth ache. Patient said the pain lasts for about 24 hours after charging to where she can't even sleep. Patient said they wanted to use the device because the device helped her, patient said that before the device she would have to take 5-6 (b)(4) so that she could get through her day without crying from pain. Patient said implant itself gets very warm. Patient said she turned implant off while charging and the same issue occurred. Patient denied any falls/trauma/emi exposure. Patient inspected rtm ((b)(4)) and found no damage to rtm, patient said rtm paddle only gets warm like normal, not hot. Troubleshooting was unable to be performed as pss redirected patient to hcp to address issue. The patient was redirected to their healthcare provider to further address the issue.
 
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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 Key11575086
MDR Text Key242460950
Report Number3004209178-2021-04986
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,Followup
Report Date 04/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2021
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 Received04/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/20/2020
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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