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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 Problems Electromagnetic Interference (1194); High impedance (1291)
Patient Problems Bruise/Contusion (1754); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2021
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2016, product type: lead, product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2016, product type: lead. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 07-jan-2020, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 06-aug-2019, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that patient had mri on (b)(6) 2021 and during the scan, the patient starting having very bad, burning pain. Caller stated this didn't resolve when the scan was stopped and patient was admitted to the hospital (b)(6) 2021 and has been constantly reporting pain. Caller stated the pain is where they typically feel stimulation which is lower back and pain shoots down left leg. Caller stated patient reportedly turned ins into mri mode before the scan and said ins was off but when tss asked if patient currently had controller with them to confirm ins was off, caller stated patient didn't have controller. Caller believed stim was currently off. Troubleshooting was unable to be performed as tss reviewed with caller that programming and device interrogation cannot be done remotely. The caller was redirected to nas to page rep. Rep saw pt in hospital early this afternoon to check on her scs system. Pt was hospitalized very late the evening of (b)(6) 2021 or very early the morning of (b)(6) 2021 due to pain symptoms. Pt hasn't been using her stimulation system because it hasn't been helpful and they were planning on removing scs system per caller. Caller doesn't know how long it's been since pt last used her scs system.  bruisingwas noted later in the day near the ins and externally near where the lead tip sites would be. Caller was told that ins put into mri mode prior to mri by husband. When caller arrived early in the afternoon today (around 1pm), the ins was in mri mode. The husband mentioned putting the ins into mri mode about 30 minutes before caller arriving to hospital. When caller looked at the diary, it was showing stim had been off for about 30 days but then it was on for 10% on (b)(6) and stim on 60% on (b)(6). To caller it was unclear that mri mode was activated at time of mri. Caller disabled mri mode and made sure that ins was off and turned to 0ma before she left hospital today. Pt weighs 150 lbs. Rep noted that today during imped check that one of pt's electrodes had imped values around 33,000 ohms but all other electrodes were normal range. Pt did not have any discomfort during imped check.

 
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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 Key12233167
MDR Text Key264999154
Report Number3004209178-2021-11484
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/15/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/14/2019
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/24/2018
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: 07/27/2021 Patient Sequence Number: 1
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