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

Model Number	N160
Medical Device Problem Codes	High impedance (1291); Delayed Charge Time (2586); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited a high out of range shock impedance measurement.Technical services (ts) was consulted and discussed stored device information as well as therapy delivery.The crt-d exhibited the elective replacement indicator (eri) battery status due to a charge time of over 15 seconds during capacitor reform.Previous data upload indicated two years of battery longevity remaining.This crt-d remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that there was no conclusive evidence that the observed out-of-range impedance measurements were due to a product performance issue or an inadequate lead-to-device connection.However, intermittent, out-of-range shock lead impedance measurements with no conclusive evidence of a performance issue or an inadequate lead-to-device connection are likely the result of the low-energy test signal utilized for daily automatic or in-clinic commanded shock lead impedance testing.A software update was released in 2015 to further improve consistency of the impedance test results and provide the clinician with additional diagnostic tools, including programmable shock lead impedance alert limits.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited a high out of range shock impedance measurement.Technical services (ts) was consulted and discussed stored device information as well as therapy delivery.The crt-d exhibited the elective replacement indicator (eri) battery status due to a charge time of over 15 seconds during capacitor reform.Previous data upload indicated two years of battery longevity remaining.This crt-d remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited a high out of range shock impedance measurement.Technical services (ts) was consulted and discussed stored device information as well as therapy delivery.The crt-d exhibited the elective replacement indicator (eri) battery status due to a charge time of over 15 seconds during capacitor reform.Previous data upload indicated two years of battery longevity remaining.This crt-d remains in service.No adverse patient effects were reported.This crt-d was explanted.A new device was implanted.No additional adverse patient effects were reported.This product has not been returned for analysis.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that there was no conclusive evidence that the observed out-of-range impedance measurements were due to a product performance issue or an inadequate lead-to-device connection.However, intermittent, out-of-range shock lead impedance measurements with no conclusive evidence of a performance issue or an inadequate lead-to-device connection are likely the result of the low-energy test signal utilized for daily automatic or in-clinic commanded shock lead impedance testing.A software update was released in 2015 to further improve consistency of the impedance test results and provide the clinician with additional diagnostic tools, including programmable shock lead impedance alert limits.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited a high out of range shock impedance measurement.Technical services (ts) was consulted and discussed stored device information as well as therapy delivery.The crt-d exhibited the elective replacement indicator (eri) battery status due to a charge time of over 15 seconds during capacitor reform.Previous data upload indicated two years of battery longevity remaining.This crt-d remains in service.No adverse patient effects were reported.This crt-d was explanted.A new device was implanted.No additional adverse patient effects were reported.This product has not been returned for analysis.

• Brand Name: INCEPTA CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
• 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: 20031129
• Report Number: 2124215-2024-52137
• Device Sequence Number: 11529169
• Product Code: LWP
• UDI-Device Identifier: 00802526480997
• UDI-Public: 00802526480997
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/23/2024

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: 11/20/2015
• Device Model Number: N160
• Device Catalogue Number: N160
• Device Lot Number: 933714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 08/28/2024; 09/05/2024; 09/20/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 08/29/2024; 09/09/2024; 09/23/2024
• Date Device Manufactured: 11/25/2013
• 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: 79 YR
• Patient Sex: Male