MAUDE Adverse Event Report: MPRI CAPSURE SENSE LEAD MRI SURESCAN; PERMANENT PACEMAKER ELECTRODE

Model Number 457453

Device Problems High impedance (1291); Decreased Sensitivity (2534); Capturing Problem (2891); Impedance Problem (2950); Unstable Capture Threshold (3269)

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

Event Date 08/01/2023

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that the right ventricular (rv) lead exhibited a gradual increase in impedance, decreased r waves, and a small increase in thresholds.It was suspected that these changes were most likely related to a physiological change at the tip tissue surface of the rv lead, such as calcification or mineralization.The rv lead remains in use. no patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the impedance trend of the right ventricular pacing lead was rising.Analysis of the device memory indicated pacing capture threshold in the right ventricle was rising.Analysis of the device memory indicated diminished right ventricular sensing.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was further reported that the rv lead exhibited varied thresholds and the impedance doubled.

• Brand Name: CAPSURE SENSE LEAD MRI SURESCAN
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19017524
• MDR Text Key: 339084940
• Report Number: 2649622-2024-08826
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P830061
• 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: 04/08/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/25/2018
• Device Model Number: 457453
• Device Catalogue Number: 457453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2016
• 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: EN1DR01 IPG