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

Model Number	G051
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Inaccurate Synchronization (1609)
Health Effect - Clinical Codes	Arrhythmia (1721); Electric Shock (2554)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient presented to the emergency room after multiple shock deliveries.Device interrogation of the event revealed repeated atrial pacing that induced a ventricular arrhythmia.Diagnostic imaging was performed and no abnormalities were noted in this system.The device data was forwarded to boston scientific technical services and is currently pending review.It is unknown at this time if the patient's left ventricular assistance device (lvad) was involved in this event.Reprogramming the atrial-ventricular sensing delay was discussed to resolve the event, but the event resolution has not yet been received.The patient was stable and at this time, the system remains implanted.
Event or Problem Description
It was reported that this patient presented to the emergency room after multiple shock deliveries.Device interrogation of the event revealed repeated atrial pacing that induced a ventricular arrhythmia.Diagnostic imaging was performed and no abnormalities were noted in this system.The device data was forwarded to boston scientific technical services and the inappropriate atrial pacing was discussed.It was stated that the physician was able to reprogram the atrial-ventricular sensing delay to resolve the event.It is unknown if the patient's left ventricular assistance device (lvad) was involved in this event.The patient was stable and the system remains implanted and in-service.

• 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
• MDR Report Key: 12112248
• Report Number: 2124215-2021-11144
• Device Sequence Number: 3427352
• Product Code: NIK
• UDI-Device Identifier: 00802526534478
• UDI-Public: 00802526534478
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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: 06/15/2019
• Device Model Number: G051
• Device Catalogue Number: G051
• Device Lot Number: 122827
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 08/03/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention