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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); Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 01/19/2021
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 who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that he had turned his stimulation off at night and didn't turn stimulation back on before he went to work and left his controller at home. Patient said he had a problem at work where the implant "turned on" by itself b/c he felt stimulation sensation while he was at work and he wasn't able to turn it off b/c he had left controller at home. Patient noted anytime he sat down stimulation went up. Patient has adaptive stimulation. Pt also works as a mechanic and was around a diesel engine and was working on a boat during the times he felt stimulation as too strong, pss reviewed information about potential emi and patient said he didn't think this was the cause and said that he had moved away from object he was near when he started feeling stimulation increase and the stimulation only started to increase more. Patient said when he got home he checked implant and stimulation said it was off. Patient said he then turned stimulation back on and stimulation sensation came on really strong so he had to turn stimulation on and off a couple more times to get stimulation to the level he wanted it at. Patient services (pss) attempted to walk pt through troubleshooting as. Pt let pss walk him through checking position for the group he was on, upright position registered correctly and pt felt stimulation comfortably. Pt understood how to adjust as. Pt knew how to turn as off and manually adjust and said he would do this until he could meet with rep. The issue was not resolved through troubleshooting. The patient was redirected to their healthcare provider to further address the issue. Pt had called hcp about issue and hcp told him to see rep. Hcp didn't know who rep was at local rep hcp had been working with recently doesn't work with mdt. Pss reviewed nas function and is emailing rep.
 
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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 Key11209199
MDR Text Key243691093
Report Number3004209178-2021-01137
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 01/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2018
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 Received01/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/28/2017
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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