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

Model Number N140

Device Problems Premature Discharge of Battery (1057); Defibrillation/Stimulation Problem (1573); Telemetry Discrepancy (1629)

Patient Problem Ventricular Fibrillation (2130)

Event Date 07/30/2021

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 which is indicative of battery voltage too low for the projected remaining capacity.Device data was preserved and submitted for boston scientific engineering review.Engineering analysis showed the battery appeared to be depleting more quickly than expected.Additionally, it was noted that the patient was found unresponsive, and had received a shock due to ventricular fibrillation (vf).An attempt was made to interrogate the device; however, they could not interrogate, and there were no beeping tones with application of a magnet.This device was subsequently explanted due to shock not delivered when required, telemetry issues, and the code 1003.A new device was implanted.No additional adverse patient effects were reported.This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 which is indicative of battery voltage too low for the projected remaining capacity.Device data was preserved and submitted for boston scientific engineering review.Engineering analysis showed the battery appeared to be depleting more quickly than expected.Additionally, it was noted that the patient was found unresponsive, and had received a shock due to ventricular fibrillation (vf).An attempt was made to interrogate the device; however, they could not interrogate, and there were no beeping tones with application of a magnet.This device was subsequently explanted due to shock not delivered when required, telemetry issues, and the code 1003.A new device was implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned cardiac resynchronization therapy defibrillator (crt-d) 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.This particular device was not included in the advisory population.

• Brand Name: ENERGEN CRT-D
• 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: 12620470
• MDR Text Key: 276362697
• Report Number: 2124215-2021-24640
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480959
• UDI-Public: 00802526480959
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S255
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

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: 09/02/2015
• Device Model Number: N140
• Device Catalogue Number: N140
• Device Lot Number: 111265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female