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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 Interrogate (1332); Energy Output Problem (1431); Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892); Communication or Transmission Problem (2896)
Patient Problems Paralysis (1997); Burning Sensation (2146); Electric Shock (2554)
Event Date 02/15/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that a couple days to a week ago the stimulator started acting weird in that stimulation sensation would change on it's own. Patient reported implant itself was getting "hot" inside his body when he was charging and when he wasn't charging it. Yesterday stimulation completely shut off. Patient reported now he wasn't able to get stimulator to charge at all because all he gets is "no device found, retry/recharge. " during call there was no physical damage found to any equipment, controller powered on with aa's. Pss walked patient through passive recharge mode and implant started charging at excellent. Implant battery was empty and controller was at 90%. Pss reviewed that patient needed to continue to charge in order to turn stimulator back on. Regarding stimulation changing on it's own, pss reviewed that patient was welcome to call for assistance with adjusting/possible adaptive stimulation issues. The issue was not resolved through troubleshooting. The patient was redirected to their healthcare provider to further address the issue. Issue of patient's ins not charging was resolved but patient's stimulation/implant getting hot were not. Additional information was received. It was reported the inside gets hot and also when the patient moved the wrong way the sensitivity changes and makes or changes the way the patient could move their head. It paralyzed them. The patient could also feel shocks some times in their body that came and went.
 
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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 Key11447261
MDR Text Key244776022
Report Number3004209178-2021-03972
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 03/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2021
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 Received03/07/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/31/2020
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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