MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORIGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number	G050
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited loss of capture during a high-rate pacing during tavi delivery.The physician decided to implant a temporary pacemaker lead into the right ventricular (rv) because 180ppm were required for tavi delivery.When stimulating at 180ppm with the temporary lead, every stimulus was capturing the ventricle.The rv and left ventricular (lv) pacing capture threshold were within normal range.The physician is now worried that rv/lv capture during atp delivery might be as unsuccessful as during this high-rate pacing attempt and had requested advice.Data has been provided for review, boston scientific technical services confirmed loss of capture on fast-rate pacing, however there was capture observed on the atp delivery and the device was able to capture.No adverse patient effects were reported.This device remains in-service.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited loss of capture during a high-rate pacing during tavi delivery.The physician decided to implant a temporary pacemaker lead into the right ventricular (rv) because 180ppm were required for tavi delivery.When stimulating at 180ppm with the temporary lead, every stimulus was capturing the ventricle.The rv and left ventricular (lv) pacing capture threshold were within normal range.The physician is now worried that rv/lv capture during atp delivery might be as unsuccessful as during this high-rate pacing attempt and had requested advice.Data has been provided for review, boston scientific technical services confirmed loss of capture on fast-rate pacing, however there was capture observed on the atp delivery and the device was able to capture.No adverse patient effects were reported.This device remains in-service.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to b5 describe event or problem for more information regarding the specific circumstances of this event.

• Brand Name: ORIGEN CRT-D
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH 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: 16457128
• Report Number: 2124215-2023-09368
• Device Sequence Number: 14041369
• Product Code: NIK
• UDI-Device Identifier: 00802526534454
• UDI-Public: 00802526534454
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P010012/S341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2023

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: 12/14/2017
• Device Model Number: G050
• Device Catalogue Number: G050
• Device Lot Number: 481323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Unknown