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); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

2024-mar-21: information was received from multiple sources (patient, manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins).The reason for call was patient stated they are trying to get an mri and the mri tech told them they can't do it unless they can put the device into mri mode.Patient stated when they try to charge the implant it is not doing anything.Patient service asked patient if they have tried charging the implant and patient said they have not charged their implant in over 12 years.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider (hcp) to further address the issue.Manufacturer representative (rep) said patient tried to get an mri earlier this week but they couldn't connect to their implant.Rep didn't have further detail.Rep to further investigate with patient. reviewed mri eligibility.Technical services(ts) recommended eligibility form. eligibility for if rep can't get patient out of overdischarge.Additional information was received from a healthcare provider (hcp) regarding an implantable neurostimulator (ins).The reason for call was caller said pt had device that had not worked for "12 years" and device was not charging and would not do anything at all.Caller said the ins was going to get replaced in the future, but caller was wondering about mri eligibility.Reviewed mri considerations.2024-apr-05: additional information was received from a manufacturer representative (rep).The rep reported that the patient said their device worked for 3 months after their surgery, but not since then.Rep's guess is that it was over discharged and the rep at the time did not tell the patient that they¿d have to meet up for a physician reset mode.Rep met with patient and tried, but it was unsuccessful since it¿s been 8 years.The patient was given the eligibility forms for mri from their pain management physician.Patient is also scheduled for a battery replacement.

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.

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

Rep reported the ins not charging occurred 8 years ago, not 12.

• 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: 19060694
• MDR Text Key: 339605993
• Report Number: 3004209178-2024-08651
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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: 12/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 05/02/2024
• Date Device Manufactured: 01/14/2016
• 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 Sex: Male