MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGENIO; PACEMAKERS

Model Number J174

Device Problems Failure to Capture (1081); Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885); Inappropriate or Unexpected Reset (2959)

Patient Problem Bradycardia (1751)

Event Date 10/11/2023

Event Type  Injury  

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that this pacemaker had entered safety mode.The patient presented to the hospital with a slow pulse.Review of a surface electrocardiogram revealed pacing spikes, however non-capture was suspected due to the patient's low heart rate.Device data noted a magnet rate of 100 beats per minute (bpm) with approximately 1 year remaining on the battery.It was noted that lead measurements were good.Additional information received reported that this pacemaker was explanted and replaced, however the leads remain in service.No additional adverse patient effects were reported.This pacemaker has been shipped for return analysis.

Event Description

It was reported that this pacemaker had entered safety mode.The patient presented to the hospital with a slow pulse.Review of a surface electrocardiogram revealed pacing spikes, however non-capture was suspected due to the patient's low heart rate.Device data noted a magnet rate of 100 beats per minute (bpm) with approximately 1 year remaining on the battery.It was noted that lead measurements were good.Additional information received reported that this pacemaker was explanted and replaced, however the leads remain in service.No additional adverse patient effects were reported.This pacemaker has been shipped for return 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/determined it had undergone resets and that bradycardia therapy remained available.The system resets occurred during a telemetry session and while communicating with the latitude remote monitoring system.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.If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: INGENIO
• Type of Device: PACEMAKERS
• 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: 18048277
• MDR Text Key: 327079880
• Report Number: 2124215-2023-61007
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/13/2024

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: 01/08/2015
• Device Model Number: J174
• Device Catalogue Number: J174
• Device Lot Number: 104682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2023
• Initial Date FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2013
• 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