MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number NEU_INS_STIMULATOR

Device Problems Battery Problem (2885); Charging Problem (2892); Connection Problem (2900); Material Integrity Problem (2978)

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 09/10/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 37761, product type: recharger.Other relevant device(s) are: product id: 37761.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient.The patient reported that their connector pin is bent, and they can¿t recharge.They stated that they need the recharger because their implantable neurostimulator (ins) is dead and they have seizures because they don¿t have it.The patient mentioned that they have complex pain syndrome that involved retractable migraines, and part of that causes them to have episodes of seizures and drop attacks.Troubleshooting could not be done at the time of the report as the patient did not have access to the product.The patient mentioned that they would be calling back.No further complications were reported or anticipated.Indication for use is unknown.

Manufacturer Narrative

This report is a duplicate report.No further reports will be submitted under this regulatory report number.Please refer to regulatory report # (b)(4) for any future reports.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.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 9169072
• MDR Text Key: 161809358
• Report Number: 3007566237-2019-02090
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• 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: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR