MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; Stimulator, spinal-cord, totally implanted for pain relief

Model Number NEU_INS_STIMULATOR

Device Problems Display or Visual Feedback Problem (1184); Failure to Interrogate (1332); Failure to Power Up (1476); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)

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

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 97745bp lot# nlh056301n serial# implanted: explanted: product type accessory product id 97745 lot# serial# (b)(6) implanted: explanted: product type programmer, patient product id 97755 lot# serial# (b)(6) implanted: explanted: product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: 97745, serial/lot #: (b)(6), ubd: , udi#: (b)(6)h3.Analysis was performed on [product id: 97745, serial/lot #:(b)(6) analysis found that the complaint was unverified.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411 g2.Foreign: br 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

Information was received from a distributor regarding a patient with an implantable neurostimulator (ins).It was reported that several problems occurred with the patient controller and recharger system.The first problem was that the patient controller was not turning on, it stopped working.Second problem was the screen was all blurred, no message appeared, the ins was not found (no communication).When charging the ins, it was taking too long to load, around 3 hours.There was a time when the device beeped and stopped working, it took 35 minutes to find the ins.The patient controller and recharger were not loading.Screen 55 displayed.It was unknown if there were any contributing factors.The battery was removed and replaced, system reset, and patient controller replaced but was all unsuccessful.The charging system was changed and the issue was resolved at the time of this report.The patient kept the new patient controller.It was noted that the ins was working.The patient was alive with no injury.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: Stimulator, spinal-cord, totally implanted for pain relief
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18897671
• MDR Text Key: 337626782
• Report Number: 2182207-2024-01719
• Device Sequence Number: 1
• Product Code: LGW
• 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: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: "SEE H11...."
• Patient Sex: Male