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

Model Number 97714

Device Problems Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Communication or Transmission Problem (2896)

Patient Problem Insufficient Information (4580)

Event Date 04/22/2022

Event Type  Injury  

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 Description

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was pt reported they were scheduled for an mri this afternoon but a mri tech called saying they needed a letter from patient's doctor because it appeared the ins was left in mri mode before the ins died.Pt stated the ins has been inoperable for 4 or 5 years and thought implant may possibly be in eos since the implant year was 2014.Pt commented they have an upcoming appointment with a surgeon on may 9, 2022 to discuss options moving forward with mdt device / therapy on whether to replace or remove ins.Pt added that if the leads were left in place they more that likely would replace the ins.Pt said the mystim controller no longer connects with the ins.Pt said they had a mri for their lower back in 2017 without any issues.Pt said they have a shoulder that is keeping them awake all night and wanted to know if pss had any advice on how to make the ins system safe to undergo the imaging.Pss reviewed expected service life of 97714 ins and possible over discharged (od) state.Pt said the last time they were able to recharge the ins was probably four years ago and this morning when they tried to connect the controller to the ins it did not do anything.Patient said the ins was very helpful so they did not have pain 24/7 so they did not need it (ins therapy) all the time so there were a couple of times the ins went into od mode.Pt said they met with a local mdt rep who did something funky to wake it up.Pt said they had a really hard time psychologically with the ins because of having to be tethered to the wall when recharging.Pt confirmed edgar ross implanted their ins and there wasn't a lot of follow-up maybe 1 or 2 times but they meet with their local mdt rep when they needed to make adjustments.The caller was redirected to follow-up with their hcp or mdt rep.  mri tech reports patient (pt) said her system is "inoperable, no longer working." additional information was received from the patient regarding an implantable neurostimulator.Pt has a letter from healthcare provider (hcp) stating that the ins is not active and has been "discharged for many years".Caller noted that the hcp also stated the scs is safe to scan in this letter.Caller is inquiring if they can proceed with mri - technical services specialist (tss) recommended confirming hcp researched system to determine eligibility, recommended hcp complete scan-type eligibility form in mri labeling.Additional information received.It was reported that pt is needing mri.Caller reports pt said the scs is not working anymore, caller speculates the ins battery is dead as the ins as not been used in many years.Caller had no additional info to provide.Caller states that they have a note from the hcp from 29 april 2022 regarding the ins; it reads ' (stimulator).Is not active and the pulse generator is completely discharged and has been for many years.' the 97714 has since been replaced with vanta ins and mri info was reviewed for the vanta and current configuration.

• Brand Name: SURESCAN
• 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: 18990638
• MDR Text Key: 338785866
• Report Number: 3004209178-2024-08014
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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
• Report Date: 03/28/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/28/2024
• Date Device Manufactured: 04/11/2014
• 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: 51 YR
• Patient Sex: Female