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

Model Number J177

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Incorrect, Inadequate or Imprecise Result or Readings (1535); Unexpected Therapeutic Results (1631); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2023

Event Type  Injury  

Manufacturer Narrative

This device was expected to be returned.Should the device be returned analysis will be conducted and this investigation will be updated.

Event Description

It was reported that the patient had reported to the health care professional that their pulse rate was fifty beats per minute.The patient was in argentina on holiday and a recent check showed nearing explant.The healthcare professional was going to contact the patient.Technical services (ts) discussed that pacing below the lower rate limit (lrl) can be present because of modified - based timing as well as premature ventricular contraction (pvc) identification.In this case, there is evidence of noise oversensing, leading to the device pacing below the lrl.Additional information was received.The device was found to be in safety mode and the patient underwent urgent device replacement.No additional adverse patient effects were reported.The device is expected to be returned for analysis.

Event Description

It was reported that the patient had reported to the health care professional that their pulse rate was fifty beats per minute.The patient was in argentina on holiday and a recent check showed nearing explant.The healthcare professional was going to contact the patient.Technical services (ts) discussed that pacing below the lower rate limit (lrl) can be present because of modified - based timing as well as premature ventricular contraction (pvc) identification.In this case, there is evidence of noise oversensing, leading to the device pacing below the lrl.Additional information was received.The device was found to be in safety mode and the patient underwent urgent device replacement.No additional adverse patient effects were reported.The device is expected to be returned for analysis.

Manufacturer Narrative

This report is being filed to update the patient identifier.

• 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: 18344824
• MDR Text Key: 330722568
• Report Number: 2124215-2023-71606
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/20/2016
• Device Model Number: J177
• Device Catalogue Number: J177
• Device Lot Number: 483092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention