MAUDE Adverse Event Report: QUALITY TECH SERVICES LLC SENSIGHT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number B32000

Device Problem Unstable (1667)

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

Event Date 01/26/2023

Event Type  malfunction  

Event Description

It was reported from the healthcare provider (hcp) to the manufacturer representative (rep) that the lead is moving when bur hole device is locked.The issue was not resolved.No symptoms reported.

Manufacturer Narrative

Concomitant medical products: product id: b3300542, lot# va2pez7v27, implanted: (b)(6) 2023, product type: lead.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

Continuation of d10: product id b3300542; lot# va2pez7v27; implanted: (b)(6) 2023; product type lead.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

Additional information was received from the manufacturer representative (rep) after discussions with the healthcare provider (hcp).The hcp had another case similar where lead movement may have occurred.Imaging comparison indicated lead movement may have occurred, however the rep and physician concluded it was related to imaging angles not being consistent.Upon another event occurring, the hcp and rep think the lead may have moved in that case as well.In regards to the device, the top cap was applied with no difficulty and when determining if the lead moved inferior or superior, it was believed the lead was 'pulled back'.There were no specifics on if the lead was within the v of the support clip (toward center or outer circumference) and no specifics on if the direction of the lead was coming out of the clip jawline, as it varies depending on the situation.Irrigation/suction was used to remove the bone debris was from the burr hole before securing the burr hole device.The centering tool was used to secure the burr hole device with two bone screws, which were placed and tighten.There were no specifics on whether the orientation of the jaw line was related to the axis alignment with the bone screws as each case is different depending on the patient anatomy.The stylet was removed with no difficulty or noticeable change from cases where no lead movement occurred.The lead was looped around the burr hole device which usually happens after cap is applied.The lead clip stayed in place when the jaw became undone.The lead holder was not loosened prior to stylet removal.The hcp was not doing anything different from implant procedures prior to (b)(6) 2023.

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.

Event Description

Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the cause of the lead moving when the burr hole device was locked wasn¿t determined or resolved.The rep noted the hcp did everything correctly during the surgery.

Event Description

An observational visit occurred where a medtronic representative observed additional implant cases with the physician.General surgical observations from these cases include use of crw frame, alpha omega w/xy stage and sensight lead holder.Observations from these other cases on typical technique include the physician inserts the support clip by pushing flat on it rather than engaging the tab opposite of the insertion tool then the insertion tool side engaged.The physician normally does not loosen the depth stops prior to stylet removal.

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): QUALITY TECH SERVICES LLC; 7842 hickory flat highway; suite d; woodstock GA 30188
• Manufacturer (Section G): QUALITY TECH SERVICES LLC; 7842 hickory flat highway; suite d; woodstock GA 30188
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16253612
• MDR Text Key: 308504845
• Report Number: 3012165443-2023-00003
• Device Sequence Number: 1
• Product Code: MHY
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2024
• Device Model Number: B32000
• Device Catalogue Number: B32000
• Device Lot Number: 082M07622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2023
• Date Device Manufactured: 03/17/2022
• 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 H10....".
• Patient Age: 72 YR
• Patient Sex: Male