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

Model Number 407658

Device Problems Electrical /Electronic Property Problem (1198); Fracture (1260); High impedance (1291); Over-Sensing (1438); Capturing Problem (2891); Impedance Problem (2950)

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

Event Date 02/01/2024

Event Type  Injury  

Event Description

It was reported that the right ventricular (rv) lead triggered a polarity switch and an alert for high unipolar pacing impedance was observed.High sensing integrity counter (sic) was also noted.A lead fracture was suspected.Monitored non-sustained ventricular tachycardia (vt) events showed non-physiologic intervals with what appeared to be oversensing.The device would be programed to the voo mode until the rv lead could be replaced.No 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

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 further reported that the rv lead also exhibited rising rv pacing impedance and rising rv thresholds.The rv lead was capped and replaced.

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 triggered a polarity switch and an alert for high unipolar pacing impedance was observed.High sensing integrity counter (sic) was also noted.A lead fracture was suspected.Monitored non-sustained ventricular tachycardia (vt) events showed non-physiologic intervals with what appeared to be oversensing.The device would be programed to the voo mode until the rv lead could be replaced.No patient complications have been reported as a result of this event.(b)(6) 2024 it was further reported that the rv lead also exhibited rising rv pacing impedance and rising rv thresholds.The rv lead was capped and replaced.It was additionally reported that impedance varied between the normal baseline and a high undefined range.

• Brand Name: CAPSUREFIX NOVUS 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: 19034501
• MDR Text Key: 339271261
• Report Number: 2649622-2024-09108
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00885074200699
• UDI-Public: 00885074200699
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/03/2017
• Device Model Number: 407658
• Device Catalogue Number: 407658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/22/2024
• Date Device Manufactured: 06/15/2015
• 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: C6TR01 CRTP, 429688 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male