MAUDE Adverse Event Report: MPRI SENSIGHT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number B3300542M

Device Problems Break (1069); Difficult to Remove (1528); Malposition of Device (2616); Material Twisted/Bent (2981); Positioning Problem (3009)

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

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from the manufacturer¿s representative (rep) who reported the healthcare provider (hcp) couldn't get the stylet out of the lead during a stage one procedure.The stylet was eventually removed, but it got to the point where the lead was stretched.Due to the difficulty removing the stylet the lead was 5 mm too deep, but the hcp was able to reposition the lead ¿just fine.¿ the lead remained implanted in the patient.

Manufacturer Narrative

Section d information references the main component of the system.Other relevant device(s) are: product id b31010 serial# unknown product type accessory product id neu_stylet_acc lot# unknown product type accessory 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 the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), who reported the stylet was discarded following the procedure with the proximal end being bent.The cause of the difficulty removing the stylet was thought to be due to the depth stop being too tight.Due to the lead being 5 mm too deep the surgeon opened the burr hole clip and pulled the lead out by 5mm; no refunneling was required.Following stage 2 implant impedance results were within normal limits.

Event Description

Additional information received from a rep via an hcp provided additional details of the stage 1 implant procedure, including that this specific instance was the second half implant of a bilateral system.The first half had occurred earlier and also noted resistance on the stylet removal, but to a lesser extent.The stylet had been removed straight up, there were no countersinks, the implant sites were smooth and clean of bone fragments, and the centering tool was used.It was noted it was difficult to use the support clip; clip was seemingly locked, but it popped open when stylet removal was first attempted.The clip was locked after 5-6 further attempts, before additional attempts to remove stylet.It was noted the rep could see spring-like reaction with the lead secured in the depth-stop.All impedance values were in range after completion of the stage 2 procedure.The surgeon suspects there could be an issue with the leksell frame.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id b31010 lot# serial# unknown implanted: explanted: product type accessory product id neu_stylet_acc lot# unknown serial# implanted: explanted: product type accessory product id neu_burrholecap lot# serial# unknown implanted: explanted: product type accessory product id neu_stylet_acc lot# unknown serial# implanted: explanted: product type accessory 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.

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: SENSIGHT
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba,pr MN 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba,pr MN 00766
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12638674
• MDR Text Key: 276588070
• Report Number: 2182207-2021-01803
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000426408
• UDI-Public: 00763000426408
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2023
• Device Model Number: B3300542M
• Device Catalogue Number: B3300542M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2024
• Date Device Manufactured: 05/06/2021
• 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 Age: 66 YR