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

Model Number B31000

Device Problem Difficult to Open or Close (2921)

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

Event Date 10/05/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the support clip was very difficult to close.It did close and then may have popped open, as it was not possible to put the cap on.Factors that may have contributed to the issue is due to a very curved skull.They changed the orientation of the support clip multiple times.The base ring remained but the support clip and cap were replaced with new ones and the issue was resolved.The clip closed and the cap was secured.

Manufacturer Narrative

H3: analysis of the accy burr hole device (lot#: 082t30721) revealed that the burr hole cap was damaged.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 PARKINSONIAN TREMOR
• 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: 15567449
• MDR Text Key: 306334646
• Report Number: 3012165443-2022-00025
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2023
• Device Model Number: B31000
• Device Catalogue Number: B31000
• Device Lot Number: 082T30721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2021
• 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 Sex: Male