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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 Problems Failure to Deliver Energy (1211); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Sleep Dysfunction (2517)
Event Date 04/16/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that patient was seeing 'settings not available' in group a. The issue started about 4-5 days ago when pt noticed the device was not keeping up with pain anymore. He got tremendous pain. Yesterday it quit all together. Pt said he was miserable, was up all night, the pain was so bad, he could not sleep. Pt was getting settings not available on group a only. Pt tried using other groups but only group a goes to that side of his back where his pain is. Group c only makes his legs tingle and does not do much for him. Pt confirmed he had no falls/no trauma. Pt is scheduled to see hcp today. Medtronic rep is supposed to be at his apt, pt did not know the name.   pt confirmed the rep was not aware of the above issue. Pt was wondering if the rep had to bring a controller replacement to resolve the message.
 
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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 Key11716593
MDR Text Key252352998
Report Number3004209178-2021-06571
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 05/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2021
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 Received05/10/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/13/2020
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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