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

Model Number NEU_INS_STIMULATOR

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2019

Event Type  Injury  

Manufacturer Narrative

This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Date of event: please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Other relevant device(s) are: product id: neu_ins_stimulator, serial/lot #: unknown.Product id: neu_unknown_lead, serial/lot #: unknown.Ortiz rm, scheperjans f, pekkonen e.Deep brain stimulation for dystonia in finland during 2007-2016.Bmc neurol.2019;19(1):137.10.1186/s12883-019-1370-y.If information is provided in the future, a supplemental report will be issued.

Event Description

Abstract: background: dystonia is a movement disorder substantially affecting the quality of life and the ability to work.A proportion of patients does not respond to first line pharmacotherapy.Deep brain stimulation (dbs) is established as a primary operative treatment option for severe drug resistant dystonia.We studied dystonia patients treated with dbs in finland between the years 2007¿2016 to evaluate the use and outcomes of dbs treatment.Methods: we analyzed the hospital records of dystonia patients, who underwent dbs operation during 2007¿2016 in finland.The clinical and technical parameters were recorded as well as preoperative assessments and treatments.The response to dbs was evaluated retrospectively using the global dystonia rating scale (gds).Results: out of 585 db implantations during the study period, 37 were done for dystonia.The clinical response improved significantly with time in the isolated focal dystonia group, and at 12 months, 22 of 32 patients had over 50% alleviation of the gds score.There was only one subclinical i intracerebral hemorrhage, and four infections leading to revision.Speech impairment and limb coordination problems were common stimulation- related adverse events and were mostly resolved or relieved with the adjustment of stimulation parameters.Conclusions: dbs seems to be beneficial in dystonia.Although dbs is indicated for dystonia in finland, the number of operations did not increase at the same rate as dbs operations in general.Dbs appears to be a safe and effective treatment for focal as well as generalized dystonia.Reported events: 1.2 patients had an ins malfunction.Both cases resolved.2.1 patient had an ins dislocation.The case resolved.3.1 patient had a contact malfunction.The case resolved.The following device specifics were provided: ins model 37601, ins model 7428, and ins model 37612.

Manufacturer Narrative

B1/b2/h1: updated as additional review indicated these three events (see b5) resulted in serious injury.B5: additional review indicated that information was missed on initial report.All 3 events updated.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

Reported events: 1.2 patients had an ins malfunction which resulted in hospital admission.Both cases resolved.2.1 patient had an ins dislocation which resulted in hospital admission.The case resolved.3.1 patient had a contact malfunction which resulted in hospital admission.The case resolved.

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: 8913496
• MDR Text Key: 167578229
• Report Number: 3007566237-2019-01796
• 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: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2020

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 Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 07/24/2019; 10/15/2020
• Supplement Dates FDA Received: 08/21/2019; 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Hospitalization