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

Model Number 97715

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Seroma (2069); Discomfort (2330); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517)

Event Date 02/18/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer¿s representative (rep).The rep reported that the cause of the discomfort was that the battery was implanted close to the spine and was causing discomfort.The original implant physician used one incision for the leads and generator.The rep reported that the discomfort was resolved.The generator was placed in the flank with more soft tissue.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator.It was reported that the patient was a having a revision surgery to reposition the implantable neurostimulator (ins) due to the ins site being uncomfortable.The discomfort was discovered a couple of weeks prior to the report.There were no reports of device issues or allegations.There were no further complications reported or 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.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

Information was received from a consumer about an implantable neurostimulator (ins) implanted for spinal pain.It was reported that the patient's implant sticks out half an inch and this makes it really difficult to sleep because she would wake up and feel like someone's fist was in her back.Patient said she wished she would've know this before getting implanted so that she could've had implant placed in different area.The patient said that she's had to go into the doctors office six times to have fluid removed out of her back (out of implant pocket) with a syringe.The patient said the area around implant was not flattening they said she had seen her previous doctor about this and he had said that the implant site should flatten out about a month post implant and it had been over month but still hadn't.The patient was going to follow up with their current hcp about the issue.The caller was to follow up with the doctor about potentially having ins moved to her bottom.Patient reported the ins was revised from their back to their front in (b)(4) 2020 because it was sticking out due to weight loss.The device now works 100% better.

• Brand Name: INTELLIS
• 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: 9836891
• MDR Text Key: 187331237
• Report Number: 3004209178-2020-05483
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 03/16/2020; 10/05/2020
• Supplement Dates FDA Received: 04/02/2020; 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR