MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGENIO; PULSE-GENERATOR, SINGLE CHAMBER, SINGLE

Model Number J172

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Bradycardia (1751); Dyspnea (1816); Fatigue (1849); Discomfort (2330)

Event Date 05/05/2023

Event Type  Injury  

Event Description

It was reported that this pacemaker was exhibiting oversensing noise and the patient reported feeling fatigue, dyspnea and discomfort.It was not known if the patient experienced pacing inhibition or asystole.Additionally, the nurse indicated that the device went into backup mode vvi 40 bpm status which could be cleared after device interrogation.When the backup mode was cleared from the device, the device reverted to normal vvir mode 60 bpm.There was an alert message indicating approximate time to explant is 4 months.Boston scientific technical services provided troubleshooting options and suggested that the healthcare professional evaluate the competitor lead for potential lead issue.The plan is to replace this pacemaker as soon as possible.The competitor lead was tested during the replacement procedure without seeing abnormalities.Subsequently, this device was replaced with a competitor pacemaker.No additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to b5 describe event or problem for more information regarding the specific circumstances of this event.

Event Description

It was reported that this pacemaker was exhibiting oversensing noise and the patient reported feeling fatigue, dyspnea and discomfort.It was not known if the patient experienced pacing inhibition or asystole.Additionally, the nurse indicated that the device went into backup mode vvi 40 bpm status which could be cleared after device interrogation.When the backup mode was cleared from the device, the device reverted to normal vvir mode 60 bpm.There was an alert message indicating approximate time to explant is 4 months.Boston scientific technical services provided troubleshooting options and suggested that the healthcare professional evaluate the competitor lead for potential lead issue.The plan is to replace this pacemaker as soon as possible.The competitor lead was tested during the replacement procedure without seeing abnormalities.Subsequently, this device was replaced with a competitor pacemaker.No additional adverse patient effects were reported.The product was returned to boston scientific but has become lost in transit.Should this product be received in the future, an updated report will be provided.

• Brand Name: INGENIO
• Type of Device: PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
• 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: 17003697
• MDR Text Key: 315944120
• Report Number: 2124215-2023-26310
• Device Sequence Number: 1
• Product Code: LWW
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/07/2014
• Device Model Number: J172
• Device Catalogue Number: J172
• Device Lot Number: 101973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male