MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCIVA? ICD DR; Implantable Cardioverter Defibrillator (ICD)

Model Number	D401
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); Failure to Charge (1085); High impedance (1291); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) system exhibited failure to charge a code 1006, indicative of a high voltage detected on a lead during a device charge.The right ventricular (rv) channel exhibited noise and intermittent shock impedance measurements, with the recent measurements being high and out of range.It was also noted that the rv lead exhibited loss of capture and high out of range pacing impedance measurements.Technical services (ts) recommended device replacement.Subsequently, this icd was explanted and replaced.No additional adverse patient effects have been reported, and this icd has not been returned for analysis.
Additional Manufacturer Narrative
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.

• Brand Name: PERCIVA? ICD DR
• 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 ; +1(651)582-6168
• MDR Report Key: 23300748
• Report Number: 2124215-2025-73262
• Device Sequence Number: 21320343
• Product Code: LWS
• UDI-Device Identifier: 00802526587894
• UDI-Public: (01)00802526587894(17)220205
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2026

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: 02/05/2022
• Device Model Number: D401
• Device Catalogue Number: D401
• Device Lot Number: 253588
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/06/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male