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

Model Number J174

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 11/04/2022

Event Type  Injury  

Manufacturer Narrative

The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Event Description

It was reported that this pacemaker was found to be operating in safety mode.An alert was issued in the remote monitoring system for this observation.The physician had hoped to program the device to aai mode, but parameters were not programmable in safety mode.The chronic right ventricular (rv) lead was known to be broken.The device was planned to be explanted and replaced the following day.It was noted the patient was admitted to the hospital due to feeling diaphragmatic stimulation from the rv lead pacing in unipolar with an output of 5v.The local sales representative confirmed the device was explanted and replaced the following day.No additional adverse patient effects were reported due to the surgery needed to replace the device.The model/serial numbers and manufacturer of the rv lead was not known, but it was reported that the rv lead remained implanted and in use.The explanted pacemaker was expected to be returned for analysis.

Event Description

It was reported that this pacemaker was found to be operating in safety mode.An alert was issued in the remote monitoring system for this observation.The physician had hoped to program the device to aai mode, but parameters were not programmable in safety mode.The chronic right ventricular (rv) lead was known to be broken.The device was planned to be explanted and replaced the following day.It was noted the patient was admitted to the hospital due to feeling diaphragmatic stimulation from the rv lead pacing in unipolar with an output of 5v.The local sales representative confirmed the device was explanted and replaced the following day.No additional adverse patient effects were reported due to the surgery needed to replace the device.The model/serial numbers and manufacturer of the rv lead was not known, but it was reported that the rv lead remained implanted and in use.The explanted pacemaker was expected to be returned for analysis.

Manufacturer Narrative

The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.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 due to system resets.It was confirmed that brady 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 related to telemetry attempts 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.

• 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: 15871758
• MDR Text Key: 304411916
• Report Number: 2124215-2022-49447
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/04/2014
• Device Model Number: J174
• Device Catalogue Number: J174
• Device Lot Number: 100725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR