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

Model Number	D413
Medical Device Problem Codes	Failure to Read Input Signal (1581); Under-Sensing (1661); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited atrial undersensing on the presenting electrogram (egm).Technical services (ts) reviewed the device data and noted that the atrial sensitivity was programmed to 0.2 mv with a measured p-wave amplitude of approximately 0.2 mv, that could potentially caused the undersensing.Additionally, high capture thresholds were noted on the non-boston scientific right atrial (ra) lead measured at approximately 4.0 v.Ts provided reprogramming options for atrial sensitivity.No adverse patient effects were reported.This icd remains in service.
Additional Manufacturer Narrative
The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.

• 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 ; 6515826168
• MDR Report Key: 25437410
• Report Number: 2124215-2026-30570
• Device Sequence Number: 10335282
• Product Code: LWS
• UDI-Device Identifier: 00802526587955
• UDI-Public: (01)00802526587955(17)260806
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/06/2026
• Device Model Number: D413
• Device Catalogue Number: D413
• Device Lot Number: 139209
• 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: 05/14/2026
• Initial Report FDA Received Date: 06/08/2026
• Date Device Manufactured: 08/19/2024
• 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
• Patient Age: 67 YR
• Patient Sex: Female