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

Model Number K184

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problems Asystole (4442); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2023

Event Type  Injury  

Event Description

It was reported that during a routine in-clinic follow-up, this pacemaker was found to have reverted to safety mode.It was noted that the device showed a battery status of 4 months remaining during the previous in-clinic follow-up.Technical services (ts) discussed device longevity can no longer be predicted at this time and recommended device replacement as soon as possible.No adverse patient effects were reported.This device remains in service.Additional information has been requested, however, no additional information is available at this time.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a routine in-clinic follow-up, this pacemaker was found to have reverted to safety mode.It was noted that the device showed a battery status of 4 months remaining during the previous in-clinic follow-up.Technical services (ts) discussed device longevity can no longer be predicted at this time and recommended device replacement as soon as possible.No adverse patient effects were reported.This device remains in service.Additional information has been requested, however, no additional information is available at this time.If information is provided in the future, a supplemental report will be issued.It was reported that the patient experienced many episodes of asystole due to the unipolar sensing in safety mode.Surgical intervention was undertaken.The device was explanted and replaced.The device return is not expected as the physician discarded the device after explant.No additional adverse patient effects were reported.

• 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: 16382896
• MDR Text Key: 309635624
• Report Number: 2124215-2023-06927
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

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: 10/09/2015
• Device Model Number: K184
• Device Catalogue Number: K184
• Device Lot Number: 113890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2013
• 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
• Patient Age: 72 YR