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

Model Number 97715

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/27/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins).It was reported that when they plug their controller into ac power, the screen would turn on but whenever they took it off of ac power to plug in the recharger (rtm), the screen would go black/unresponsive.The pt was walked through removing the battery pack, plugging the controller into the ac power supply, pt confirmed it powered on; controller only powers on with ac power supply.Pt inspected the controller battery compartment and said the first two pins didn't look shiny like the other two pins.An email was sent to the repair department to replace the controller.Pt mentioned they needed to get everything recharged for an mri they have on monday.Pt said they have had trouble recharging previously where they could just take the battery out of the controller to reset and that would resolve the issue but this time that did not resolve their problem.Pt called back because the received their replacement controller and said they are still having the same issues as reported in this case.Pt said their controller screen goes black and unresponsive when they plug in their recharger antenna to charge their implant.Pt said that they tried this with their previous controller and replacement controller that was sent.Pt said their was no visible to the rtm.When the pt was asked to start a charging session with their implant and replacement controller to try to replicate the problem (controller screen going black and unresponsive) the pt became escalated and said that they don't want to do anymore with the equipment.The pt was informed that a replacement rtm could be sent and the pt refused and said they didn't want anymore replacements to be sent.Pt said that they had to cancel their mri two times now and the mri is trying to find out if a brain tumor is growing or not.Pt said that they have had nothing but "problems" with the device since implant and just want the surgeon to remove the device at this point.Pt abruptly ended the call.No symptoms were reported.Additional information was received.It was reported that the patient (pt) called back with the reference number for a letter they received from medtronic.Pt said that they need their implant replaced because they have had nothing but problems and they have already been sent extra parts and the patient said that calling in to report things is too much work.Pt said that they were just sent a different controller and this still doesn't resolve the issue.Pt mentioned that their doctor retired.The pt was mailed physician listings for implanting doctors (to discuss implant replacement) to the address on file as requested by the pt.Pt said that they will send back replacement external equipment to medtronic once they get their implant replaced.

Manufacturer Narrative

Concomitant medical products: product id 97745 serial# (b)(6) product type programmer, patient product id 97755 serial# (b)(6) product type recharger.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 received from the patient reported that actions planned to resolve the issue is to have the implant removed.The patient reported that they have a weight of 215lbs.

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12516051
• MDR Text Key: 272873228
• Report Number: 3004209178-2021-14278
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2021
• Date Device Manufactured: 07/31/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 98 KG