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

Model Number	N164
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) device was exhibiting oversensing of the respiratory rate trend (rrt) sensor.Boston scientific technical services walked the boston scientific representative through how to program the rrt sensor off on this device product family.No other details were provided.In addition, there were intermittent high out of range pace impedance measurements greater than 2500 ohms observed on the right atrial (ra) lead impedance trend.The products remain in-service.No patient symptoms or 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 this device exhibited intermittent fluctuations in impedance measurements with no conclusive evidence of a product malfunction; please refer to the description for more information regarding the specific circumstances of this event.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) device was exhibiting oversensing of the respiratory rate trend (rrt) sensor.Boston scientific technical services walked the boston scientific representative through how to program the rrt sensor off on this device product family.No other details were provided.In addition, there were intermittent high out of range pace impedance measurements greater than 2500 ohms observed on the right atrial (ra) lead impedance trend.The products remain in-service.No patient symptoms or adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) device was exhibiting oversensing of the respiratory rate trend (rrt) sensor.Boston scientific technical services walked the boston scientific representative through how to program the rrt sensor off on this device product family.No other details were provided.In addition, there were intermittent high out of range pace impedance measurements greater than 2500 ohms observed on the right atrial (ra) lead impedance trend.The products remain in-service.No patient symptoms or adverse patient effects were reported.Additional information was received that the ra lead has been exhibiting intermittent high out of range pace impedance measurements greater than 2500 ohms for five years.In addition, there have been inappropriate atrial tachycardia response (atr) episodes stored due to ra lead noise which is being oversensed.In at least one recent episode, there was pacing inhibition of greater than two seconds observed due to the oversensed noise, but it was noted that the patients intrinsic ra beats are also observed.Boston scientific technical services (ts) confirmed that these issues are consistent with a fractured lead.The boston scientific field representative indicated that the plan is to explant and replace the fractured ra lead and to prepare for all possible outcomes of the case, they asked ts for the appropriate lead adaptor model number to have in case it is needed.The products remain in-service at this time.No patient symptoms or 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 this device exhibited intermittent fluctuations in impedance measurements with no conclusive evidence of a product malfunction; please refer to the description for more information regarding the specific circumstances of this event.
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 this device exhibited intermittent fluctuations in impedance measurements with no conclusive evidence of a product malfunction; please refer to the description for more information regarding the specific circumstances of this event.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) device was exhibiting oversensing of the respiratory rate trend (rrt) sensor.Boston scientific technical services walked the boston scientific representative through how to program the rrt sensor off on this device product family.No other details were provided.In addition, there were intermittent high out of range pace impedance measurements greater than 2500 ohms observed on the right atrial (ra) lead impedance trend.The products remain in-service.No patient symptoms or adverse patient effects were reported.Additional information was received that the ra lead has been exhibiting intermittent high out of range pace impedance measurements greater than 2500 ohms for five years.In addition, there have been inappropriate atrial tachycardia response (atr) episodes stored due to ra lead noise which is being oversensed.In at least one recent episode, there was pacing inhibition of greater than two seconds observed due to the oversensed noise, but it was noted that the patients intrinsic ra beats are also observed.Boston scientific technical services (ts) confirmed that these issues are consistent with a fractured lead.The boston scientific field representative indicated that the plan is to explant and replace the fractured ra lead and to prepare for all possible outcomes of the case, they asked ts for the appropriate lead adaptor model number to have in case it is needed.The products remain in-service at this time.No patient symptoms or adverse patient effects were reported.Additional information was received that the ra lead and this crt-d device were subsequently explanted and replaced.No additional 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: 12741913
• Report Number: 2124215-2021-33819
• Device Sequence Number: 7625656
• Product Code: LWP
• UDI-Device Identifier: 00802526481031
• UDI-Public: 00802526481031
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/27/2023

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: 07/15/2016
• Device Model Number: N164
• Device Catalogue Number: N164
• Device Lot Number: 106095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 11/02/2021; 11/15/2023; 11/17/2023
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 01/28/2022; 11/21/2023; 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male