MAUDE Adverse Event Report: MPRI CAPSUREFIX NOVUS LEAD MRI SURESCAN; PERMANENT PACEMAKER ELECTRODE

Model Number 5076-58

Device Problems High impedance (1291); High Capture Threshold (3266)

Patient Problems Asystole (4442); Heart Block (4444)

Event Date 03/08/2024

Event Type  Injury  

Event Description

It was reported that two hours post implant procedure, the patient experienced exit block and asystole.It was noted that the right ventricular (rv) lead exhibited high thresholds and high impedance.Rv lead was explanted and replaced. no further patient complications have been reported as a result of this event.

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.

Manufacturer Narrative

Product event summary: the full lead was returned and analyzed.No anomalies were found.The distal low voltage electrode of the lead was covered in body t issue/fibrotic growth.The helix of the lead was extrinsically bent.Visual analysis of the lead indicated damage at implant.The analyst noted all electrical testing was within specified parameters.No insulation or conductor fracture was observed.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: CAPSUREFIX NOVUS 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: 18947409
• MDR Text Key: 338184151
• Report Number: 2649622-2024-07731
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P930039
• 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: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5076-58
• Device Catalogue Number: 5076-58
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2024
• 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: Q70A2 IPG, 5076-52 LEAD.
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Female