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

Model Number	N160
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439); Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding the device serial number and patient outcome.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) exhibited farfield signal oversensing and atrial undersensing with competitive pacing while in a mode switch.Technical services (ts) discussed troubleshooting options and programming considerations.Multiple attempts have been made to obtain additional information regarding the model/serial number and patient information without success.At this time no further information is available.If additional information becomes available this report would be updated at that time.Evidence suggests this crt-d remains in service and no adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited farfield signal oversensing and atrial undersensing with competitive pacing while in a mode switch.Technical services (ts) discussed troubleshooting options and programming considerations.Multiple attempts have been made to obtain additional information regarding the model/serial number and patient information without success.At this time no further information is available.If additional information becomes available this report would be updated at that time.Evidence suggests this crt-d remains in service and no adverse patient effects were reported.Additional information received reported that the observations associated with this cardiac resynchronization therapy defibrillator (crt-d) system were due to atrial flutter response (afr) having been programmed on.Furthermore, this crt-d was explanted and replaced due to normal battery depletion (nbd) later that day.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.Correction to d4: serial number was updated to (b)(6).Correction to d6a/d6b: implant date and explant date provided via medical records upon locating the serial number.

• 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 degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18994203
• Report Number: 2124215-2024-18889
• Device Sequence Number: 14202398
• Product Code: LWP
• UDI-Device Identifier: 00802526480997
• UDI-Public: 00802526480997
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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: 09/11/2016
• Device Model Number: N160
• Device Catalogue Number: N160
• Device Lot Number: 969259
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2014
• 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: 78 YR
• Patient Sex: Male