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

Model Number J177

Device Problems High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Impedance Problem (2950); Inappropriate or Unexpected Reset (2959)

Patient Problem Asystole (4442)

Event Date 01/22/2024

Event Type  Injury  

Event Description

It was reported that the patient with this pacemaker was seen in the hospital for a routine follow-up visit.During device interrogation, a reset was triggered due to an increase in impedance, and an asystole of approximately 10 seconds was observed.Boston scientific was contacted and recommendation to replace the device was suggested since the patient is pacemaker dependent.The patient was kept in the hospital.Subsequently, the device was explanted and replaced.There were no additional adverse patient effects reported.The device is expected to return for analysis.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that the patient with this pacemaker was seen in the hospital for a routine follow-up visit.During device interrogation, a reset was triggered due to an increase in impedance, and an asystole of approximately 10 seconds was observed.Boston scientific was contacted and recommendation to replace the device was suggested since the patient is pacemaker dependent.The patient was kept in the hospital.Subsequently, the device was explanted and replaced.There were no additional adverse patient effects reported.The device was returned 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: 18622637
• MDR Text Key: 334321834
• Report Number: 2124215-2024-05596
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/16/2015
• Device Model Number: J177
• Device Catalogue Number: J177
• Device Lot Number: 101677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention