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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 Electromagnetic Interference (1194)
Patient Problems Pain (1994); Sleep Dysfunction (2517); Insufficient Information (4580)
Event Date 10/05/2021
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 non-malignant pain. The reason for call was pt reported a return of symptoms (bad pain up the leg) after they had a dental implant placed on tuesday. Pt stated the stimulator is implanted for the pt's sciatic nerve issue. Pt stated they did not use a drill during the dental procedure and the pt ensured to notify the dentist about the stimulator. Pt mentioned they took tylenol pm and oral hydrocodone because they were unable to sleep last night. Pt used the controller to confirm stimulation is on, set to group a (only group available) and they have 4 programs but only use program 4 because it worked best. Pt stated during the day they usually have the stimulation set to 1. 2 during the day and lower the stimulation down to 0. 6 at night because they don't like the stimulation sensation while they try to sleep. Pt was currently set to 1. 3 and the pt is still experiencing pain. The patient was redirected to their healthcare provider to further address the issue. The patient mentioned unrelated medical history including pt mentioned having ankle issues which they had steroid injections for, and a surgery about a month and a week ago. Pt is currently wearing a surgical "boot" while the ankle heals and pt said the ankle is sore. Pt stated they had a front tooth that broke off, an implant placed on tuesday which fell out overnight and a temporary tooth was placed yesterday. Pt mentioned 3-4 months ago they also noticed they are urinating more often. Pt provided hcp info as dr. Abraham but was unsure who would necessarily be considered the "managing" hcp. Caller was redirected to the healthcare provider (hcp).
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12609061
MDR Text Key279627777
Report Number3004209178-2021-15170
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 11/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2021
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Date Manufacturer Received10/29/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/07/2020
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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