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

Model Number	D400
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that three days post implantation of this implantable cardioverter defibrillator (icd) device, the patient visited the emergency room (er) due to inappropriate anti-tachycardia pacing (atp) therapy delivery.The health care professional (hcp) called technical services (ts) and requested review of the stored events.Upon review of the presenting electrogram (egm), ts was able to confirm that the four bursts of atp therapy were inappropriately delivered due to noise on the right ventricular (rv) channel.Ts also noted that there was a signal artifact monitor (sam) episode recorded on the device, further review of the sam episode showed the rv lead exhibit noise and low out of range pacing impedances which led to the respiratory sensor to be disabled.Ts discussed with the hcp programming options.The hcp stated to discuss with the physician on plans to turn off right ventricular (rv) lead therapy and perform a venogram.At this time, the icd and rv lead remain in service.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that three days post implantation of this implantable cardioverter defibrillator (icd) device, the patient visited the emergency room (er) due to inappropriate anti-tachycardia pacing (atp) therapy delivery.The health care professional (hcp) called technical services (ts) and requested review of the stored events.Upon review of the presenting electrogram (egm), ts was able to confirm that the four bursts of atp therapy were inappropriately delivered due to noise on the right ventricular (rv) channel.Ts also noted that there was a signal artifact monitor (sam) episode recorded on the device, further review of the sam episode showed the rv lead exhibit noise and low out of range pacing impedances which led to the respiratory sensor to be disabled.Ts discussed with the hcp programming options.The hcp stated to discuss with the physician on plans to turn off right ventricular (rv) lead therapy and perform a venogram.At this time, the icd and rv lead remain in service.No additional adverse patient effects were reported.Subsequent additional information was received from the field representative that reported that therapy was temporarily turned off and a couple days later a replacement procedure was performed.The physician explanted the icd device and surgically abandoned the rv lead.The physician replaced the icd and rv lead with new devices successfully.No additional adverse patient effects were reported.

• Brand Name: PERCIVA ICD VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
• 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: 19763673
• Report Number: 2124215-2024-44330
• Device Sequence Number: 8506739
• Product Code: LWS
• UDI-Device Identifier: 00802526587863
• UDI-Public: 00802526587863
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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: 07/02/2025
• Device Model Number: D400
• Device Catalogue Number: D400
• Device Lot Number: 115125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 07/23/2024
• Date Device Manufactured: 07/12/2023
• 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: 48 YR
• Patient Sex: Male