MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number NEU_INS_STIMULATOR

Device Problems High impedance (1291); Migration or Expulsion of Device (1395)

Patient Problems Neurological Deficit/Dysfunction (1982); Therapeutic Effects, Unexpected (2099); Ambulation Difficulties (2544)

Event Date 05/28/2019

Event Type  malfunction  

Manufacturer Narrative

This event was previously reported under manufacturer's report #3004209178-2018-26849.New information received indicated the ins was replaced due to normal depletion and the impedance issue was not resolved.Any new information regarding this event will be submitted under this report.Concomitant medical products: product id: 3389-40, lot#: 0209051773, implanted: (b)(6) 2015, product type: lead.Other relevant device(s) are: product id: 3389-40, serial/lot #: (b)(4), ubd: 16-oct-2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care provider (hcp) of a clinical study regarding a patient who was implanted with a neurostimulator (ins) for dystonia.The patient experienced worsening dystonia of the right upper limb on (b)(6) 2018, which was well controlled after surgery.The device was reprogrammed at this time.By (b)(6) 2018, patient symptoms including worsening of abnormal movement and the physicians suspected lead migration, and the device was reprogrammed again.Imaging was performed (b)(6) 2018, but results were pending.By (b)(6) 2018, there was still no improvement.The ins was reprogrammed a third time, and the patient was hospitalized from june 9 to june 11 because of worsening with the last parameters.On (b)(6) 2018, the device was interrogated, and high impedances were found on the left lead: electrode 0 at 4,253 ohms; electrode 1 at 4,015 ohms; electrode 2 at 4,929 ohms; and electrode 3 at 6,435 ohms.The device was again reprogrammed.The event was considered ongoing at the time of this report.The etiology was described as related to device/procedure, and not related to implant procedure.No further complications were reported.Additional information was received.No actions had been taken since the last reprogramming session, and the cause of the high impedance was not determined.The next consultation with patient was scheduled in (b)(6) 2019.No further complications were reported.Additional information was received.Lead migration had not been confirmed and the results were still pending.Additional information was received.It was reported that the ins was replaced due to normal depletion on (b)(6) 2019, and there was no improvement in impedance.Refer to manufacturer report 3004209178-2018-26849 for details pertaining to the previous main device of this system.

Event Description

Additional information was received.Left lead migration was confirmed (b)(6) 2019.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8710367
• MDR Text Key: 148418089
• Report Number: 3007566237-2019-01328
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 06/29/2019; 10/14/2020
• Supplement Dates FDA Received: 07/08/2019; 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR