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

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.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.It was reported that for a couple of months, patient stated she could not sleep, was falling a lot, dizzy, and had tremors so bad she could not hold a fork.Patient stated they were losing weight and ins was bulging out.Patient stated they had to use an adaptor and it was making a hole in the hip.Patient stated leads were in head and she was having huge knots in the back of their head and something was poking out.Patient stated it hurt to touch and was in so much pain in their head and neck.Patient reported they were implanted for migraines and that they had a history of seizures since before implant.No further complications were reported/anticipated.

• Brand Name: ITREL 4
• Type of Device: STIMULATOR, 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
• MDR Report Key: 10088562
• MDR Text Key: 192040489
• Report Number: 3004209178-2020-09139
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169107793
• UDI-Public: 00643169107793
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• Device Model Number: 37703
• Device Catalogue Number: 37703
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1