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

Model Number	97713
Medical Device Problem Codes	Failure to Deliver Energy (1211); Battery Problem (2885)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins).The reason for call was patient reported they are not feeling stimulation on the right side of their body since a couple days ago.Patient stated the left side is working.Patient service asked if patient had a fall or trauma and patient said in the last couple years.Agent asked patient to connect with the controller and patient said the controller show the implant is on and they can adjust the stimulation on both sides, but when they increase the stimulation on the right side they are not feeling stimulation.Agent reviewed patient services role.The issue was not resolved.The patient was redirected to their healthcare provider (hcp) to further address the issue.On (b)(6) 2024 pt called back and re-reported not feeling stimulation on the right side of their body.Pt reported the stimulation stopped working on the right side about september 2nd and they couldn't get a hold of anyone because of the holidays, so they finally got together with their rep today.They met because their stimulator wasn't working and was to call patient services to request a programmer replacement, as rep thought this was part of the problem.Patient mentioned they have an appointment with hcp next wednesday to help explain what's going on with the stimulator and get the battery changed, and the rep told them to get a patient programmer overnighted to them so they could have it with them for this appointment.Pt also mentioned the rep thinks the ins battery will be out in a month or so and they will have to get a new battery too.Agent asked if there was something specific with the programmer t hat was going on, and patient stated that they were having a lot of problems getting it to turn on.Patient clarified the programmer turns on, but it seemed like no matter where they put the antenna, they would have difficulties connecting to their ins.Patient noted they use an antenna because they have had their shoulder replaced on both shoulders, but they did try connecting to the ins with and without the antenna, but this did not make any difference.Agent had patient reset the programmer and attempt to connect to the implanted neurostimulator.Patient was able to successfully connect to their implant with the antenna a couple times and confirmed they are on group c.Patient verified no damage to the antenna cord, the programmer battery compartment, or the programmer antenna jack.Patient stated the programmer issue started 'around (b)(6).' pt stated the rep reprogrammed their ins and they now feel stimulation on their right side again.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received from a manufacturer representative (rep).The rep reported that the implantable neurostimulator (ins) will be replaced-awaiting date and authorization.Rep saw patient (pt) in office reprogrammed to get better coverage - patient is stating 80 percent relief.Programmer was having difficulty finding ins but an agent spoke with pt and determined that it didn't need to be replaced.Healthcare provider (hcp) and office will keep us updated.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Continuation of d10: product id 97740 serial# (b)(6): product type programmer, patient medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SURESCAN
• Common Device Name: 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20280042
• Report Number: 3004209178-2024-19031
• Device Sequence Number: 7453999
• Product Code: LGW
• UDI-Device Identifier: 00643169109490
• UDI-Public: 00643169109490
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2016
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 09/30/2024; 10/28/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/22/2024; 11/18/2024
• Date Device Manufactured: 03/16/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male