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

Model Number	N164
Medical Device Problem Codes	Difficult to Remove (1528); Connection Problem (2900); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If the product is returned, analysis would be performed and this report would be updated at that time.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted and replaced due to normal battery depletion.Reportedly, in the same replacement procedure, the non-bsc right ventricular (rv) and right atrial (ra) leads were explanted due to noisy signals.The ra lead was stuck in this device header and had to be cut to be removed.Subsequently, this crt-d was successfully replaced, it is not expected to be returned for analysis and no adverse patient effects were reported.
Additional Manufacturer Narrative
If the product is returned, analysis would be performed and this report would be updated at that time.Corrected fields: b2 (outcomes attrib to adv event) - hospitalization was added.B5 (event problem) - orthography errors were corrected.H6 (device codes) - corrected with the use of more pertinent codes.H6 (impact codes) - corrected with the use of more pertinent codes.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted and replaced due to normal battery depletion.Reportedly, in the same replacement procedure, the non-bsc right ventricular and right atrial (ra) leads were explanted due to noisy signals.The ra lead was stuck in this device header and had to be cut to be removed.Subsequently, this crt-d was successfully replaced, it is not expected to be returned for analysis and no additional adverse patient effects were reported.
Additional Manufacturer Narrative
If the product is returned, analysis would be performed, and this report would be updated at that time.Corrected fields: b2 (outcomes attrib to adv event) - hospitalization was added b5 (event problem) - orthography errors were corrected h6 (device codes) - corrected with the use of more pertinent codes h6 (impact codes) - corrected with the use of more pertinent codes upon receipt at our post market quality assurance laboratory, the cardiac resynchronization therapy defibrillator (crt-d) was thoroughly inspected and analyzed.Visual inspection found a missing right atrial (ra) plug.The ra setscrew was difficult to move due to blood at the end of the ra port.A review of the device memory log found that while implanted, the device recorded no suspicious faults or resets.The laboratory analysis confirmed an induced damage on this crt-d.However, this damage is not deemed to indicate a product defect or malfunction.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted and replaced due to normal battery depletion.Reportedly, in the same replacement procedure, the non-boston scientific right ventricular and right atrial (ra) leads were explanted due to noisy signals.The ra lead was stuck in this device header and had to be cut to be removed.Subsequently, this crt-d was successfully replaced and returned for analysis.No additional adverse patient effects were reported.

• 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: 14212093
• Report Number: 2124215-2022-13246
• Device Sequence Number: 13913678
• Product Code: LWP
• UDI-Device Identifier: 00802526481031
• UDI-Public: 00802526481031
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2023

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: 06/28/2014
• Device Model Number: N164
• Device Catalogue Number: N164
• Device Lot Number: 101684
• 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: 03/11/2022
• Supplement Date Received by Manufacturer: 06/24/2022; 05/04/2023
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 06/24/2022; 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male