MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS VERSA IPG; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number VEDR01

Device Problem Pacing Problem (1439)

Patient Problem Bradycardia (1751)

Event Date 08/23/2023

Event Type  malfunction  

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 patient experienced bradycardia with a heart rate in the thirties in beats per minute (bpm) noted.The right ventricular (rv) lead exhibited low impedance.The implantable pulse generator (ipg) was pacing below the lower programmed rate of seventy bpm.The rv lead and ipg remain in use. no further patient complications have been reported as a result of this event.

• Brand Name: VERSA IPG
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SN 486056
• Manufacturer (Section G): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SN 486056
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 18994785
• MDR Text Key: 339089108
• Report Number: 3008973940-2024-02236
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00643169709072
• UDI-Public: 00643169709072
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980035
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2019
• Device Model Number: VEDR01
• Device Catalogue Number: VEDR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Date Device Manufactured: 10/08/2017
• 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: 4068-45 LEAD, 402452 LEAD
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 59 KG