MAUDE Adverse Event Report: MPRI SPRINT FIDELIS; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 694958

Device Problems Failure to Capture (1081); High impedance (1291); Under-Sensing (1661)

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

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: dtpb2d1 crtd implanted: (b)(6) 2021; 419688 lead implanted: (b)(6) 2021.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 atrial (ra) lead appeared to be undersensing triggering device classified false termination of atrial tachycardia/atrial fibrillation (at/af) events at times.It was noted that the undersensing appears to result in inappropriate atrial pacing.It was also noted that the right ventricular (rv) lead had a lead warning for high and undefined impedance measurements.It was further reported that the rv lead had a possible capture issue noted on stored episodes and ventricular capture was unable to be confirmed.It was noted that the rv lead exhibited possible undersensing.Both leads remain in use.No patient complications have been reported as a result of this event.

• Brand Name: SPRINT FIDELIS
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 19120279
• MDR Text Key: 340633275
• Report Number: 2649622-2024-10487
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P920015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2024

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: 07/11/2007
• Device Model Number: 694958
• Device Catalogue Number: 694958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/16/2024
• Date Device Manufactured: 07/22/2005
• 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: 407652 LEAD.
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 119 KG