MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGENIO; IMPLANTABLE PACEMAKER

Model Number K173

Device Problem Battery Problem (2885)

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

Event Date 03/21/2024

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this implantable pacemaker exhibited longevity calculations from 1.5 years remaining to 5 months remaining in a span of 7 months.Boston scientific technical services (ts) discussed that it could be that device had switched from approximation to actual voltage-based assessment and this was why change occurred and suggested to send in files for analysis to confirm.This device remains in service.No adverse patient effects were reported.

• Brand Name: INGENIO
• Type of Device: IMPLANTABLE 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: 19040415
• MDR Text Key: 339334434
• Report Number: 2124215-2024-20529
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526516825
• UDI-Public: 00802526516825
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970003/S132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/16/2017
• Device Model Number: K173
• Device Catalogue Number: K173
• Device Lot Number: 394581
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2015
• 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 Age: 83 YR
• Patient Sex: Female