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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 97716
Device Problems Energy Output Problem (1431); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Device Overstimulation of Tissue (1991); Insufficient Information (4580)
Event Date 12/17/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that since implant the stimulation has not resolved pain. Patient reported they met with rep and had re-programming done. Patient reports they were put on program c. It was reported that when laying down sleeping they can hardly get out of bed and depending on how they are laying they sometimes still have to crawl out of bed. Patient reported on program c they intermittently get settings not available, can not provide desired intensity. Patient reported when rep switched patient to program c, stimulation zoomed down their leg and had to turn it down.  pt states at the clinic program c showed it was on then when she got home the screen was showing "setting not available can not provide desired intensity" and then later it was and it has been switching from working to not working. Pss reviewed "setting not available can not provide desired intensity". Pt will try to monitor when the "setting not available can not provide desired intensity" comes up on the controller and in what position her bodyis in. Pt states she normally has to decrease stim when she lays down. Pt states she does not have adaptive stim. The patient was redirected to their healthcare pro vider to further address the issue. Pss reviewed pt may have to have the impedances checked.
 
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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 Key11278722
MDR Text Key230284810
Report Number3004209178-2021-01952
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 02/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2021
Device Model Number97716
Device Catalogue Number97716
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/04/2020
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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