MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TELIGEN; IMPLANTABLE PACEMAKER

Model Number E110

Device Problems Device Alarm System (1012); Premature Discharge of Battery (1057); Battery Problem (2885)

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

Event Date 02/13/2022

Event Type  Injury  

Event Description

It was reported that the battery of this implantable cardioverter defibrillator (icd) was suspected to be depleting prematurely as it decreased to 5 months of battery life remaining faster than expected.Additionally, the device presented some beeping tones suspected to be caused by a fault code 1003.This is indicative of battery voltage too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis is still pending since files are required in pgd format and there was only pdf available, with this type of format it is not possible to conduct data analysis.The device remains in service and the patient has been scheduled for device replacement.No adverse patient effects were reported.

Event Description

It was reported that the battery of this implantable cardioverter defibrillator (icd) was suspected to be depleting prematurely as it decreased to 5 months of battery life remaining faster than expected.Additionally, the device presented some beeping tones suspected to be caused by a fault code 1003.This is indicative of battery voltage too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis is still pending since files are required in pgd format and there was only pdf available, with this type of format it is not possible to conduct data analysis.The device has been explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned cognis teligen was analyzed.The battery voltage was lower than expected, but still supported full device function.Using historical daily battery voltage measurement data, engineers determined that this device was demonstrating behavior consistent with a high current condition associated with a compromised low voltage capacitor connected to the device battery.Low voltage capacitors are used in the high voltage charging operation in order to facilitate fast charge times.The behavior of these capacitors resulted in a high current drain, which was depleting the device battery faster than normal.Boston scientific has issued an advisory communication regarding an older subset of cognis/teligen devices that is more susceptible to this anomaly.Specifically, the performance of a low voltage capacitor may be compromised over time, causing an increased current drain that can lead to premature battery depletion.This particular device was included in the advisory population.

Event Description

It was reported that the battery of this implantable cardioverter defibrillator (icd) was suspected to be depleting prematurely as it decreased to 5 months of battery life remaining faster than expected.Additionally, the device presented some beeping tones suspected to be caused by a fault code 1003.This is indicative of battery voltage too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis is still pending since files are required in pgd format and there was only pdf available, with this type of format it is not possible to conduct data analysis.The device has been explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: TELIGEN
• Type of Device: IMPLANTABLE PACEMAKER
• 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: 14107708
• MDR Text Key: 289262195
• Report Number: 2124215-2022-10288
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2022

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: 09/01/2010
• Device Model Number: E110
• Device Catalogue Number: E110
• Device Lot Number: 128048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 04/04/2022; 08/18/2022
• Supplement Dates FDA Received: 05/21/2022; 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2009
• 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
• Patient Age: 71 YR
• Patient Sex: Male