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

Model Number K184

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439); Inappropriate or Unexpected Reset (2959)

Patient Problems Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Loss of consciousness (2418); Asystole (4442)

Event Date 11/22/2023

Event Type  Injury  

Event Description

It was reported that interrogation of this pacemaker with a programmer during a routine in clinic follow up noted the device had reverted to safety mode.Upon completion of the device interrogation, the patient experienced dizziness and low blood pressure.The patient was noted to be pacemaker dependent.The patient was then transferred via ambulance to the hospital for a device replacement procedure.During the ambulance transfer, periods of loss of capture (loc)/no pacing with asystole up to eight seconds was noted.The patient experienced a loss of consciousness.Surgical intervention was undertaken.During the procedure, frequent periods of loss of pacing was noted and was felt to likely be related to myopotential oversensing as it happened most often during patient movement.The device was successfully explanted and replaced.No additional adverse patient effects were reported.The return of the product has been requested.This report will be updated upon return and completion of analysis.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode and that bradycardia therapy remained available.The system resets occurred during a telemetry session and caused the device to enter safety mode.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance resulted in the system resets due to temporary high-power consumption and subsequent reversion to safety mode operation.Boston scientific has issued a field safety notice regarding ingenio extended life (el) and cardiac resynchronization therapy pacemaker (crt-p) devices that may exhibit this behavior.This particular device is included in the high impedance in ingenio extended life (el) pacemaker and crt-p advisory population.

Event Description

It was reported that interrogation of this pacemaker with a programmer during a routine in clinic follow up noted the device had reverted to safety mode.Upon completion of the device interrogation, the patient experienced dizziness and low blood pressure.The patient was noted to be pacemaker dependent.The patient was then transferred via ambulance to the hospital for a device replacement procedure.During the ambulance transfer, periods of loss of capture (loc)/no pacing with asystole up to eight seconds was noted.The patient experienced a loss of consciousness.Surgical intervention was undertaken.During the procedure, frequent periods of loss of pacing was noted and was felt to likely be related to myopotential oversensing as it happened most often during patient movement.The device was successfully explanted and replaced.No additional adverse patient effects were reported.The return of the product has been requested.This report will be updated upon return and completion of analysis.The product has been received for analysis.

• 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: 18241529
• MDR Text Key: 329406371
• Report Number: 2124215-2023-68004
• 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,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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: 01/31/2015
• Device Model Number: K184
• Device Catalogue Number: K184
• Device Lot Number: 112412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2013
• 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: 76 YR