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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ITREL 4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. ITREL 4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37703
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Fall (1848); Pain (1994); Scar Tissue (2060); Dizziness (2194); Complaint, Ill-Defined (2331); Shaking/Tremors (2515); Sleep Dysfunction (2517); Electric Shock (2554)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the consumer regarding a patient who was implanted with a neurostimulator for spinal cord stimulation. It was reported that the patient had bariatric surgery in (b)(6) 2019 and as a result the patient lost 80-90 lbs over the next 9 months. Patient stated the ins was protruding out a lot. Patient stated that the door of her walk intub will catch on it sometimes. Patient stated she felt it sticking her and she was getting a shock at the ins site in the past few days. Patient stated she noticed a hole at the incision site and it was scabbed over in the past few days. No further complications were reported/anticipated.
 
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Brand NameITREL 4
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 Key10088562
MDR Text Key192040489
Report Number3004209178-2020-09139
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 06/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2018
Device Model Number37703
Device Catalogue Number37703
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/30/2017
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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