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 Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

On 2024-jan-30 information was received from a healthcare provider regarding a patient (pt) who was implanted with an implantable ne urostimulator (ins).Pt is needing cervical mri.Caller reports the ins battery is dead.On (b)(6) 2024 information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was patient said they needed to enter mri mode but could not because they could not recharge their implanted device.Pt stated their implant had been dead for 2 years and they wanted it out of their back, but they could not get it removed for 2 months.Pt stated they were experiencing a pain in their shoulder, but could not get it resolved because they could not get an mri due to the implant not able to enter mri mode.Pt stated about 18 months ago patient tried to charge the implant, but could not connect.Pt stated 2 years ago they stopped charging the implant because they felt like the battery in the recharger and implant were not lasting long enough.Pt clarified that was actually in 2020 when the issue began.Pt talked to their rep about the issue sometime late last year and the rep said it would have to be a long session to get it going again.The rep offered to get the implant out of overdischarge then, but pt could not make an appointment.Patient also noted their implant was in their lumbar region and the mri was in the cervical area.Agent emailed the field to requesting them to contact the pt.On (b)(6) 2024 it was clarified that the patient had let the implant deplete and had not charged the ins for 2 years.The pt wanted to have the implanted removed, however the pt will have to wait 2 months before they are able to have the implant removed.

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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19159870
• MDR Text Key: 340791916
• Report Number: 3004209178-2024-09554
• 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,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2024

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: 07/28/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/22/2024
• Date Device Manufactured: 08/30/2017
• 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: Female