MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGENIO; PACEMAKER

Model Number J176

Device Problem Premature Discharge of Battery (1057)

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

Event Date 03/18/2021

Event Type  Injury  

Event Description

It was reported that the battery of this implantable device was suspected to be depleting prematurely.This device was replaced and is expected to be returned to boston scientific for analysis.No additional adverse patient effects were reported.

Event Description

It was reported that the battery of this implantable device was suspected to be depleting prematurely.This device was replaced and was returned to boston scientific for analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

The product was returned to boston scientific, and a subsequent laboratory analysis was conducted.The analysis determined that this device exhibited sensing of chronic high atrial rates which impacted battery longevity over time.Chronic high atrial sensing rates, such as for patients with chronic atrial fibrillation, can reduce longevity in devices that are programmed with atrial sensing on.Device power consumption increases proportional to the additional processing for sensed atrial events.As a result, the high rate of atrial sensing can result in the longevity being lower than expected, as observed with this device.

• Brand Name: INGENIO
• Type of Device: PACEMAKER
• 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: 16064401
• MDR Text Key: 306298521
• Report Number: 2124215-2022-55371
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/09/2015
• Device Model Number: J176
• Device Catalogue Number: J176
• Device Lot Number: 104712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2013
• 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): Required Intervention; Hospitalization