MAUDE Adverse Event Report: MPRI CAPSURE FIX MRI; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)

Model Number 5086MRI52

Device Problems Failure to Capture (1081); Capturing Problem (2891); High Capture Threshold (3266)

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

Event Date 10/16/2023

Event Type  malfunction  

Event Description

It was reported that the  exhibited decrease in p wave amplitude.Intermittent under-sensing and/or blanking was noted on the atrial lead during atrial tachycardia/atrial fibrillation (at/af) events, on stored electrograms (egm), at times resulting in false termination of at/af events and inappropriate atrial pacing.High and chronically elevated threshold was noted on the right ventricular (rv) lead and significant decrease in rv threshold also observed on lead trends.Capture was unable to confirm on the rv lead.The leads remain in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Continuation of d10: w1dr01 ipg implanted on (b)(6) 2022.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: CAPSURE FIX MRI
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)
• 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: 18976910
• MDR Text Key: 338553472
• Report Number: 2649622-2024-08134
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00613994657367
• UDI-Public: 00613994657367
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090013
• 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
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2012
• Device Model Number: 5086MRI52
• Device Catalogue Number: 5086MRI52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Date Device Manufactured: 02/01/2011
• 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: 5086MRI45 LEAD
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 87 KG