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

Model Number	G051
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was found to be operating in safety mode, indicating the device was providing limited therapy and was non-programmable.No adverse patient effects were reported.The patient was hospitalized for immediate device replacement; however, the procedure was subsequently rescheduled and was performed 10 days later.The explanted device was returned for analysis.
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the product was performed.Review of device memory confirmed the presence of a higher-than-normal current drain condition.Electrical testing and analysis were then conducted, which isolated the high current to an anomaly in an oxide layer within a custom integrated circuit component.This anomaly caused a high current drain, which over time resulted in the reported clinical observations.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was found to be operating in safety mode, indicating the device was providing limited therapy and was non-programmable.No additional adverse patient effects were reported.The patient was hospitalized for immediate device replacement; however, the procedure was subsequently rescheduled and was performed 10 days later.

• 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: 12756391
• Report Number: 2124215-2021-34500
• Device Sequence Number: 11825722
• Product Code: NIK
• UDI-Device Identifier: 00802526534478
• UDI-Public: 00802526534478
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P010012/S341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2022

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: 10/16/2020
• Device Model Number: G051
• Device Catalogue Number: G051
• Device Lot Number: 130181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2018
• 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 Sex: Male