MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VITALIO; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number K273

Device Problem Interrogation Problem (4017)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762)

Event Date 09/14/2022

Event Type  Injury  

Event Description

It was reported that this patient presented to the emergency room (er) for a heart rate of 20 beats per minute (bpm) and went into cardiac arrest.This pacemaker could not be interrogated and had no response to a magnet due to battery depletion.A x-ray was performed to confirm device information.Subsequently, this device was explanted then replaced with a new pacemaker.No additional adverse patient effects were reported.

Event Description

It was reported that this patient presented to the emergency room (er) for a heart rate of 20 beats per minute (bpm) and went into cardiac arrest.This pacemaker could not be interrogated and had no response to a magnet due to battery depletion.A x-ray was performed to confirm device information.Subsequently, this device was explanted and replaced with a new pacemaker.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, analysis confirmed the clinical observation of unable to perform interrogation due to battery depletion.The device case was opened, and visual inspection revealed no irregularities.Testing found that the battery had depleted with a normal current drain.It was determined that there was a battery anomaly that resulted in a voltage was too low to support telemetry.

• Brand Name: VITALIO
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15457599
• MDR Text Key: 300266386
• Report Number: 2124215-2022-36967
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526516962
• UDI-Public: 00802526516962
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970003/S143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/30/2017
• Device Model Number: K273
• Device Catalogue Number: K273
• Device Lot Number: 406210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Male