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

Model Number E102

Device Problems Premature Discharge of Battery (1057); Noise, Audible (3273)

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

Event Date 11/05/2022

Event Type  Injury  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) exhibited beeping tones.Boston scientific technical services (ts) referred the patient back to the clinic and discussed reasons for beeping.Additional information indicated that the device recorded a code 1003, which is indicative of battery voltage too low for the projected remaining capacity.The battery voltage was dropping in an irregular fashion, and this could possibly be related to an internal electrical short of the battery.Moreover, a device replacement was recommended.Additional information indicated that the device was explanted due to premature battery depletion (pbd).No additional adverse patient effects were reported.

Manufacturer Narrative

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

Event Description

It was reported that this implantable cardioverter defibrillator (icd) exhibited beeping tones.Boston scientific technical services (ts) referred the patient back to the clinic and discussed reasons for beeping.Additional information indicated that the device recorded a code 1003, which is indicative of battery voltage too low for the projected remaining capacity.The battery voltage was dropping in an irregular fashion, and this could possibly be related to an internal electrical short of the battery.Moreover, a device replacement was recommended.Additional information indicated that the device was explanted due to premature battery depletion (pbd).No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.The returned implantable cardioverter defibrillator (icd) was analyzed, and a review of the device memory confirmed that a low voltage alert, code 1003, was recorded.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 not included in the advisory population.

• Brand Name: TELIGEN
• 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: 15801070
• MDR Text Key: 303700154
• Report Number: 2124215-2022-47276
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

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: 05/26/2012
• Device Model Number: E102
• Device Catalogue Number: E102
• Device Lot Number: 270676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/05/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 01/10/2023
• Supplement Dates FDA Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2011
• 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: 62 YR
• Patient Sex: Male