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

Model Number	N164
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that upon this patient's cardiac resynchronization therapy defibrillator explant procedure, it was switched into electrocautery mode, however, pacing inhibition was noted during the burst of electrocautery.The device was reprogrammed to another setting and the issue remained.Technical services (ts) review this case and stated that this behavior would only be expected if the command was not received by the device or if changes not applied.Electrocautery mode screen was confirmed.Ts asked if could send screenshot of the screen, but this was unavailable.The caller sales representative indicated the plan was to connect a backup pacing support.Further information was received, the patient suffered more than 2 seconds of asystole due to this issue.The backup pacing support work adequately and the procedure was carried on successfully.No adverse patient effects were reported.
Event or Problem Description
It was reported that upon this patient's cardiac resynchronization therapy defibrillator explant procedure, it was switched into electrocautery mode, however, pacing inhibition was noted during the burst of electrocautery.The device was reprogrammed to another setting and the issue remained.Technical services (ts) review this case and stated that this behavior would only be expected if the command was not received by the device or if changes not applied.Electrocautery mode screen was confirmed.Ts asked if could send screenshot of the screen, but this was unavailable.The caller sales representative indicated the plan was to connect a backup pacing support.Further information was received, the patient suffered more than 2 seconds of asystole due to this issue.The backup pacing support work adequately and the procedure was carried on successfully.This device was eventually returned for analysis and no additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this cardiac resynchronization therapy defibrillator was thoroughly inspected and analyzed.The baseline testing completed on the device found no failing conditions.All testing completed on the device passed or was not applicable.The brady pacing not delivered when required allegation was not confirmed.

• 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: 12662520
• Report Number: 2124215-2021-31518
• Device Sequence Number: 4852980
• Product Code: LWP
• UDI-Device Identifier: 00802526481031
• UDI-Public: 00802526481031
• Combination Product (Y/N): N
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2021

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: 05/09/2015
• Device Model Number: N164
• Device Catalogue Number: N164
• Device Lot Number: 104017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 12/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Patient Sex: Female