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

Model Number	B3301542M
Medical Device Problem Codes	Connection Problem (2900); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that when connecting the lead test cable to the sensight lead, and performing the connectivity test the test would not verify.The manufacturer representative (rep) ensured that the stylet in the lead was pushed down before placing the lead in the measuring tool, and the surgical team verified they did.Rep also confirmed they turned the lead test cable on the lead 90 degrees clockwise and counterclockwise and they did.It was made sure to wipe down the lead before placing the lead test cable on the lead, and the connectivity test would not verify.Rep tried these steps once more and the connectivity test would not verify. a new lead test cable was opened, however, the connectivity test would still not verify.The troubleshooting events were repeated, and nothing changed.A new sensight lead was opened and used the lead test cable, ran the connectivity test and it verified after the new lead was opened and implanted.The issue was resolved.No symptoms reported.Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the cause of the lead connectivity issue wasn¿t determined.
Additional Manufacturer Narrative
H3.Analysis of the lead (s/n (b)(6) found no anomaly.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SENSIGHT
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18663910
• Report Number: 2649622-2024-03511
• Device Sequence Number: 8063182
• Product Code: PJS
• UDI-Device Identifier: 00763000426446
• UDI-Public: 00763000426446
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2025
• Device Model Number: B3301542M
• Device Catalogue Number: B3301542M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female