MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCIVA ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	D400
Medical Device Problem Codes	Failure to Convert Rhythm (1540); Defective Device (2588); Interrogation Problem (4017)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Electric Shock (2554)
Date of Event	03/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) experienced cardiac arrest.The patient needed to be externally resuscitated and was treated in a hospital setting and hospitalized in the icu.It was noted this device was unable to be interrogated.No magnet response was found.Different programmers were used, however, interrogation of the device was not successful.A device system revision is scheduled in the near future.No additional adverse patient effects were reported.At this time, this device system remains in service.
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) experienced cardiac arrest.The device delivered an electric shock, however, it was not successful.The patient needed to be externally resuscitated and was treated in a hospital setting and hospitalized in the icu.It was noted this device was unable to be interrogated.No magnet response was found.Different programmers were used, however, interrogation of the device was not successful.A device system revision is scheduled in the near future.Additional information was received that a device changeout procedure was performed and this device was explanted and replaced.During the procedure, the non boston scientific right ventricular (rv) lead was tested and out of range pacing impedance measurements were obtained.Visual inspection confirmed a lead fracture.This lead was capped and a new lead was implanted.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) experienced cardiac arrest.The device delivered an electric shock, however, it was not successful.The patient needed to be externally resuscitated and was treated in a hospital setting and hospitalized in the icu.It was noted this device was unable to be interrogated.No magnet response was found.Different programmers were used, however, interrogation of the device was not successful.A device system revision is scheduled in the near future.Additional information was received that a device changeout procedure was performed and this device was explanted and replaced.During the procedure, the non boston scientific right ventricular (rv) lead was tested and out of range pacing impedance measurements were obtained.Visual inspection confirmed a lead fracture.This lead was capped and a new lead was implanted.No additional adverse patient effects were reported.This device has been received for analysis.
Additional Manufacturer Narrative
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.

• Brand Name: PERCIVA ICD VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 16659458
• Report Number: 2124215-2023-15321
• Device Sequence Number: 20642343
• Product Code: LWS
• UDI-Device Identifier: 00802526587863
• UDI-Public: 00802526587863
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2023

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: 02/07/2021
• Device Model Number: D400
• Device Catalogue Number: D400
• Device Lot Number: 109889
• 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: 03/25/2023
• Supplement Date Received by Manufacturer: 04/04/2023; 10/31/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 04/11/2023; 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2019
• 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; Life Threatening; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female