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

Model Number	N164
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Data analysis confirmed low voltage fault.Moreover, it was noted that the device hardware was not detecting the loss of battery energy.The battery status indicators are not reflecting the depletion condition and are inaccurate which should no longer be relied in determining the depletion status of the device.Furthermore, the device was malfunctioning and should be replaced then return for a detailed analysis.Additional information indicated that the device changeout was not yet scheduled as patient had osteomyelitis which is not device related and was waiting for the infection to clear prior to scheduling the changeout.Also, the device has tripped explant.This device remains in service, and there were no adverse patient effects 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.Data analysis confirmed low voltage fault.Moreover, it was noted that the device hardware was not detecting the loss of battery energy.The battery status indicators are not reflecting the depletion condition and are inaccurate which should no longer be relied in determining the depletion status of the device.Furthermore, the device was malfunctioning and should be replaced then return for a detailed analysis.Additional information indicated that the device changeout was not yet scheduled as patient had osteomyelitis which is not device related and was waiting for the infection to clear prior to scheduling the changeout.Also, the device has tripped explant.This device remains in service, and there were no adverse patient effects reported.Additional information received indicated that the device exhibited premature battery depletion (pbd).This device was surgically explanted and replaced.Furthermore, the device will be returned.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.
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.Data analysis confirmed low voltage fault.Moreover, it was noted that the device hardware was not detecting the loss of battery energy.The battery status indicators are not reflecting the depletion condition and are inaccurate which should no longer be relied in determining the depletion status of the device.Furthermore, the device was malfunctioning and should be replaced then return for a detailed analysis.Additional information indicated that the device changeout was not yet scheduled as patient had osteomyelitis which is not device related and was waiting for the infection to clear prior to scheduling the changeout.Also, the device has tripped explant.This device remains in service, and there were no adverse patient effects reported.Additional information received indicated that the device exhibited premature battery depletion (pbd).This device was surgically explanted and replaced.Furthermore, the device will be returned.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.The returned device was thoroughly inspected and analyzed.Review of device memory confirmed that a low voltage alert code 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: 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: 16990776
• Report Number: 2124215-2023-25879
• Device Sequence Number: 7126408
• Product Code: LWP
• UDI-Device Identifier: 00802526481031
• UDI-Public: 00802526481031
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: 2023
• 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
• Report Date (Section B): 10/04/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/14/2016
• Device Model Number: N164
• Device Catalogue Number: N164
• Device Lot Number: 106133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 06/19/2023; 09/13/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/11/2023; 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2014
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White