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

Model Number K187

Device Problem Inappropriate or Unexpected Reset (2959)

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

Event Date 10/05/2023

Event Type  Injury  

Event Description

It was reported that this pacemaker reverted to safety mode resulting in a message in the remote home monitoring system.Technical services (ts) discussed device settings in safety mode and recommended interrogation of the device with a programmer.No further assistance was requested at this time.No adverse patient effects were reported.This device remains in service.Additional information has been requested.If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that this pacemaker reverted to safety mode resulting in a message in the remote home monitoring system.Technical services (ts) discussed device settings in safety mode and recommended interrogation of the device with a programmer.No further assistance was requested at this time.No adverse patient effects were reported.This device remains in service.Additional information has been requested.If pertinent information is provided in the future, a supplemental report will be submitted.It was reported that surgical intervention was undertaken.The device was explanted and replaced.No additional adverse patient effects were reported.The return of the product is not expected as the device was discarded following implant.

• Brand Name: INGENIO
• 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: 17905906
• MDR Text Key: 325299706
• Report Number: 2124215-2023-55973
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

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: 01/25/2015
• Device Model Number: K187
• Device Catalogue Number: K187
• Device Lot Number: 111262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 10/16/2023
• Supplement Dates FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 78 YR