MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORIGEN MINI ICD DR; IMPLANTABLE DEVICE

Model Number	D002
Medical Device Problem Codes	Material Integrity Problem (2978); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right ventricular (rv) lead of the implantable cardioverter defibrillator (icd) system exhibited high pacing thresholds.It was observed that blood was present in the rv channel of the icd header and the icd was explanted and replaced without complication.The icd is expected to be returned to the manufacturer for analysis.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that the right ventricular (rv) lead of the implantable cardioverter defibrillator (icd) system exhibited high pacing thresholds.It was observed that blood was present in the rv channel of the icd header and the icd was explanted and replaced without complication.The icd was returned to the manufacturer for analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.High power visual inspection of the header noted a hole in the rv seal plug, which allowed blood to flow into the rv lead barrel.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing and sensing functions were tested.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.

• Brand Name: ORIGEN MINI ICD DR
• Common Device Name: IMPLANTABLE DEVICE
• 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: 12643303
• Report Number: 2124215-2021-27113
• Device Sequence Number: 3313537
• Product Code: LWS
• UDI-Device Identifier: 00802526533747
• UDI-Public: 00802526533747
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2022

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: 06/27/2019
• Device Model Number: D002
• Device Catalogue Number: D002
• Device Lot Number: 112295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female