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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

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problem Overheating of Device (1437)
Patient Problems Inflammation (1932); Irritation (1941); Pain (1994); Burning Sensation (2146); Complaint, Ill-Defined (2331)
Event Date 03/11/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received by a manufacturing representative (rep) regarding a patient with an implantable neurostimulator (ins) for spinal pain. Information was reported that the patient has "sensitivity over their ins" while recharging. The rep wanted to slow down the recharging speed today. The patient has not had a recent surgery and no signs of skin irritation. The rep changed the recharge speed from 4 to 3, and will be following up with the patient later on to see if the change in recharging speed has helped. Additional information received from a manufacturer representative (rep). It was reported that the patient had warming/heating/irritation at the pocket site while recharging. The recharging speed was decreased, but this did not help the patient so a pocket revision was performed on (b)(6) 2019. The pocket was going to be moved, however the hcp decided that since the patient had an immune compromising condition, they were only going to make the existing pocket deeper to reduce infection risk. The rep spoke with the patient on (b)(6)2020- who stated that everything was fine after the revision, but now the patient had inflammation over the pocket site. The inflammation happened both while recharging and after normal ins use for about an hour. It was noted the pocket is very close to the patient's chronic pain site and the patient is thin. The ins has been turned off due to sensation. The ins worked for the pain, but the irritation at the pocket site had gotten equally painful so the device was turned off. The patient believed it may be an issue with the existing ins. The patient was going to follow up with an appointment with the rep and hcp. No further complications were reported.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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 Key9974753
MDR Text Key188207275
Report Number3004209178-2020-07348
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 company representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/11/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/17/2020 Patient Sequence Number: 1
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