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

Model Number	N160
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The local area field representative was contacted for additional information.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) and right ventricular (rv) defibrillation lead had triggered a red alert due to a high out-of-range shock impedance measurement greater than 125 ohms.Technical services (ts) reviewed troubleshooting options and possible causes.This crt-d system remains in service at this time.No adverse patient effects were reported.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.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 malfunction or an inadequate lead-to-device connection.However, intermittent, out-of-range shock lead impedance measurements with no conclusive evidence of a malfunction 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) and right ventricular (rv) defibrillation lead had triggered a red alert due to a high out-of-range shock impedance measurement greater than 125 ohms.Technical services (ts) reviewed troubleshooting options and possible causes.This crt-d system remains in service at this time.No adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and right ventricular (rv) defibrillation lead had triggered a red alert due to a high out-of-range shock impedance measurement greater than 125 ohms.Technical services (ts) reveiwed troubleshooting options and possible causes.This crt-d system remains in service at this time.No adverse patient effects were reported.Additional information received reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted and replaced due to normal battery depletion (nbd).The shock impedance measurement was 87 ohms for the chronic right ventricular (rv) defibrillation lead and the new crt-d at implant.The rv lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.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 malfunction or an inadequate lead-to-device connection.However, intermittent, out-of-range shock lead impedance measurements with no conclusive evidence of a malfunction 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.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.The associated investigation determined that there was no conclusive evidence that the observed out-of-range impedance measurements were due to a malfunction or an inadequate lead-to-device connection.However, intermittent, out-of-range shock lead impedance measurements with no conclusive evidence of a malfunction 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) and right ventricular (rv) defibrillation lead had triggered a red alert due to a high out-of-range shock impedance measurement greater than 125 ohms.Technical services (ts) reveiwed troubleshooting options and possible causes.This crt-d system remains in service at this time.No adverse patient effects were reported.Additional information received reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted and replaced due to normal battery depletion (nbd).The shock impedance measurement was 87 ohms for the chronic right ventricular (rv) defibrillation lead and the new crt-d at implant.The rv lead remains in service.No adverse patient effects were reported.

• 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: 17447524
• Report Number: 2124215-2023-41159
• Device Sequence Number: 7537455
• Product Code: LWP
• UDI-Device Identifier: 00802526480997
• UDI-Public: 00802526480997
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 06/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/19/2016
• Device Model Number: N160
• Device Catalogue Number: N160
• Device Lot Number: 947276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 08/18/2023; 03/22/2024; 06/13/2024
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 08/25/2023; 04/16/2024; 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2014
• 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
• Patient Age: 75 YR
• Patient Sex: Female