MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGENIO; PACEMAKER

Model Number J177

Device Problems Premature Discharge of Battery (1057); Telemetry Discrepancy (1629); Battery Problem (2885)

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

Event Date 03/29/2024

Event Type  Injury  

Event Description

It was reported that the battery of this implantable pacemaker is suspected to be depleting prematurely.The pacemaker was unable to be interrogated, though the last device follow-up showed an estimated longevity of two years remaining.This pacemaker was successfully replaced and is expected to be returned to boston scientific for analysis.No additional adverse patient effects were reported.

• 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: 19041869
• MDR Text Key: 339433320
• Report Number: 2124215-2024-20576
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/25/2015
• Device Model Number: J177
• Device Catalogue Number: J177
• Device Lot Number: 102338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization