MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA CRT-D; CARDIAC RESYNCHRONIZATION THERAPY WITH A DEFIBRILLATOR

Model Number	N161
Medical Device Problem Codes	Premature Discharge of Battery (1057); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Boston scientific technical services (ts) then advised to send data for analysis and assisted in saving data to programmer then exporting data.Additional information was received indicating that engineering analysis result showed that the power of this device had a couple recent power increase, including one programmer interrogation.Moreover, two separate code 1003 were noted, one after a small power spike and the other a couple day after the power spike from telemetry.Furthermore, it was determined that this fault appears to be false positive.The voltage was following the expected voltage based on the power and the latest fault can be cleared and no further actions are required.Ts also explained that device will continue beeping until interrogate with a programmer.Further data analysis was performed, and result showed that this device exhibited premature battery depletion (pbd).Ts then recommended device replacement.To date, this device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
At this time, the product has not been returned.If the product is returned and analysis will be performed, a supplemental report will be filed if there is any further relevant information from that review.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Boston scientific technical services (ts) then advised to send data for analysis and assisted in saving data to programmer then exporting data.Additional information was received indicating that engineering analysis result showed that the power of this device had a couple recent power increase, including one programmer interrogation.Moreover, two separate code 1003 were noted, one after a small power spike and the other a couple day after the power spike from telemetry.Furthermore, it was determined that this fault appears to be false positive.The voltage was following the expected voltage based on the power and the latest fault can be cleared and no further actions are required.Ts also explained that device will continue beeping until interrogate with a programmer.Further data analysis was performed, and result showed that this device exhibited premature battery depletion (pbd).Ts then recommended device replacement.Subsequently, this device was explanted.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Boston scientific technical services (ts) then advised to send data for analysis and assisted in saving data to programmer then exporting data.Additional information was received indicating that engineering analysis result showed that the power of this device had a couple recent power increase, including one programmer interrogation.Moreover, two separate code 1003 were noted, one after a small power spike and the other a couple day after the power spike from telemetry.Furthermore, it was determined that this fault appears to be false positive.The voltage was following the expected voltage based on the power and the latest fault can be cleared and no further actions are required.Ts also explained that device will continue beeping until interrogate with a programmer.Further data analysis was performed, and result showed that this device exhibited premature battery depletion (pbd).Ts then recommended device replacement.Subsequently, this device was explanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed.Review of device memory confirmed that a low voltage alertcode 1003) was recorded.A high current drain was detected, but the battery still supported full device function.Detailed analysis confirmed the identified high current drain was a result of compromised low voltage capacitors.Low voltage capacitors are used in the device's high voltage charging operation in order to facilitate fast charge times.Investigation has determined that the low voltage capacitors can become compromised due to the presence of excess hydrogen gas within the device case.The issue with these capacitors resulted in a high current drain, which was depleting this device's battery faster than normal.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Boston scientific technical services (ts) then advised to send data for analysis and assisted in saving data to programmer then exporting data.Additional information was received indicating that engineering analysis result showed that the power of this device had a couple recent power increase, including one programmer interrogation.Moreover, two separate code 1003 were noted, one after a small power spike and the other a couple day after the power spike from telemetry.Furthermore, it was determined that this fault appears to be false positive.The voltage was following the expected voltage based on the power and the latest fault can be cleared and no further actions are required.Ts also explained that device will continue beeping until interrogate with a programmer.Further data analysis was performed, and result showed that this device exhibited premature battery depletion (pbd).Ts then recommended device replacement.Subsequently, this device was explanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Correction to field b1.Adverse event/product problem.The returned device was thoroughly inspected and analyzed.Review of device memory confirmed that a low voltage alertcode 1003) was recorded.A high current drain was detected, but the battery still supported full device function.Detailed analysis confirmed the identified high current drain was a result of compromised low voltage capacitors.Low voltage capacitors are used in the device's high voltage charging operation in order to facilitate fast charge times.Investigation has determined that the low voltage capacitors can become compromised due to the presence of excess hydrogen gas within the device case.The issue with these capacitors resulted in a high current drain, which was depleting this device's battery faster than normal.

• Brand Name: INCEPTA CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY WITH A DEFIBRILLATOR
• 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: 19707706
• Report Number: 2124215-2024-42428
• Device Sequence Number: 17855377
• Product Code: LWP
• UDI-Device Identifier: 00802526481000
• UDI-Public: 00802526481000
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/01/2025

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/29/2016
• Device Model Number: N161
• Device Catalogue Number: N161
• Device Lot Number: 501794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 07/10/2024; 02/28/2025; 04/29/2025
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/31/2024; 03/27/2025; 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male