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

Model Number K087

Device Problems Premature Discharge of Battery (1057); Inappropriate or Unexpected Reset (2959)

Patient Problem Dizziness (2194)

Event Date 08/28/2023

Event Type  Injury  

Event Description

It was reported that the patient implanted with this pacemaker presented to the emergency department with complaint of dizziness.Review of an electrogram (egm) showed large pacing spikes consistent with the device operating in vvi at 72 beats per minute (bpm).It was suspected that the device had reverted to safety mode.It was noted the device showed a battery status of one year remaining at a previous in clinic follow up approximately 2 months ago.The physician planned to have the patient contact their regular cardiologist to schedule a device replacement procedure on an unknown future date.No adverse patient effects were reported.This device remains in service.Additional information has been requested, however, no additional information is available or known at this time.If pertinent information is provided in the future, a supplemental report will be submitted.

Manufacturer Narrative

This report is being filed to correct field: d6a: implant date.

Event Description

It was reported that the patient implanted with this pacemaker presented to the emergency department with complaint of dizziness.Review of an electrogram (egm) showed large pacing spikes consistent with the device operating in vvi at 72 beats per minute (bpm).It was suspected that the device had reverted to safety mode.It was noted the device showed a battery status of one year remaining at a previous in clinic follow up approximately 2 months ago.The physician planned to have the patient contact their regular cardiologist to schedule a device replacement procedure on an unknown future date.No adverse patient effects were reported.This device remains in service.Additional information has been requested, however, no additional information is available or known at this time.If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that the patient implanted with this pacemaker presented to the emergency department with complaint of dizziness.Review of an electrogram (egm) showed large pacing spikes consistent with the device operating in vvi at 72 beats per minute (bpm).It was suspected that the device had reverted to safety mode.It was noted the device showed a battery status of one year remaining at a previous in clinic follow up approximately 2 months ago.The physician planned to have the patient contact their regular cardiologist to schedule a device replacement procedure on an unknown future date.No adverse patient effects were reported.This device remains in service.Additional information has been requested; however, no additional information is available or known at this time.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.

Manufacturer Narrative

This product is being evaluated in our post market quality assurance laboratory.This report will be updated when evaluation is complete.

Event Description

It was reported that the patient implanted with this pacemaker presented to the emergency department with complaint of dizziness.Review of an electrogram (egm) showed large pacing spikes consistent with the device operating in vvi at 72 beats per minute (bpm).It was suspected that the device had reverted to safety mode.It was noted the device showed a battery status of one year remaining at a previous in clinic follow up approximately 2 months ago.The physician planned to have the patient contact their regular cardiologist to schedule a device replacement procedure on an unknown future date.No adverse patient effects were reported.This device remains in service.Additional information has been requested, however, no additional information is available or known at this time.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 expected.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.The product has been received for analysis.

Manufacturer Narrative

This product is being evaluated in our post market quality assurance laboratory.This report will be updated when evaluation is complete.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device determined it had undergone resets 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.

• Brand Name: ADVANTIO
• 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: 17694412
• MDR Text Key: 322777409
• Report Number: 2124215-2023-48456
• 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: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/12/2024

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: 01/15/2015
• Device Model Number: K087
• Device Catalogue Number: K087
• Device Lot Number: 111224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 08/28/2023; 10/09/2023; 02/07/2024
• Supplement Dates FDA Received: 09/06/2023; 10/30/2023; 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2013
• 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: 79 YR
• Patient Sex: Male