MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. REVO MRI SURESCAN; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	RVDR01
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Codes	Bradycardia (1751); Chest Pain (1776); Dyspnea (1816)
Date of Event	02/25/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the patient experienced chest pain, shortness of breath.It was noted that the implantable pulse generator (ipg) was pacing below the programmed lower rate and the patient experienced bradycardia.It was also reported that the right ventricular (rv) lead exhibited undersensing and the right atrial (ra) lead exhibited undersensing triggering device classified false termination of atrial tachycardia/atrial fibrillation (at/af) events at times.The ipg system remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: REVO MRI SURESCAN
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19191106
• Report Number: 3004209178-2024-09824
• Device Sequence Number: 7734879
• Product Code: LWP
• UDI-Device Identifier: 00643169493407
• UDI-Public: 00643169493407
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P090013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/14/2019
• Device Model Number: RVDR01
• Device Catalogue Number: RVDR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 04/26/2024
• Date Device Manufactured: 07/20/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5076-58 LEAD, 5076-52 LEAD
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 90 KG