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

Model Number 97715

Device Problems Disconnection (1171); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Ambulation Difficulties (2544); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 17-may-2023, udi#: (b)(4); product id: 97 7a260, serial/lot #:(b)(4), ubd: 17-may-2023, udi#: (b)(4).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.It was reported that while the patient was charging last night, they used "60% of their battery" and "normally 45 minute charge takes them down to like 30%".The patient said that since they were charging earlier, they thought "well, it will use up 40% of the battery".The patient thought what was weird was they charged for 45 mins and only used "30% of their battery" and patient said that "it's never done that".The patient also said that their back has been hurting more than usual.The patient said that they were concerned that a lead has come undone.The patient said that this is the first time this has happened.The patient said that one time, they accidentally turned off their stimulation and did not know they did; patient said they turned the power off.The patient said that when they accidentally did this in the past, within 24 hours they could hardly walk.The patient said that yesterday was just a really bad day and when they went to charge "it only used half the power to charge".The patient said that normally if they are at 30% "it takes 70% charge to 100".  the patient said that the pain started probably yesterday morning.The patient said that in the past, "it usually take 24 hours" like the time they "turned it off" but this time "it was like 12 hours." the patient was redirected to their healthcare provider to further address the issue.

Event Description

Additional information received.Patient reported it was taking about 50% of remote/battery to recharge ins but all leads are connected fine.Cause was not determined.Patient given a new controller.Issue resolved.

Manufacturer Narrative

Product id: 977a260, serial# (b)(6), product type: lead; product id: 977a260, serial# (b)(6), product type: lead; product id: 97745, serial# unknown, product type: programmer, patient.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.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, 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
• MDR Report Key: 12361011
• MDR Text Key: 267918842
• Report Number: 3004209178-2021-12850
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

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: 05/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 09/07/2021
• Supplement Dates FDA Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 66 YR
• Patient Weight: 82