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

Model Number	D401
Medical Device Problem Codes	Signal Artifact/Noise (1036); Premature Discharge of Battery (1057); Over-Sensing (1438); 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	01/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1003, which states that the voltage is too low for projected remaining capacity.A request was made to have data from this device analyzed.Data analysis showed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.Additionally, this patient experienced an episode in which 1 early ventricular sense blanked out the right atrial (ra) beat.The ventricle became greater than atrium and anti-tachycardia pacing (atp) was inappropriately delivered.Technical services (ts) provided programming optimization and while reviewing observed some previous false atrial tachy response (atr) episodes with noise on both the ra and shock channels, with oversensing only on the ra.This icd remains in service at this time.No adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1003, which states that the voltage is too low for projected remaining capacity.A request was made to have data from this device analyzed.Data analysis showed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.Additionally, this patient experienced an episode in which 1 early ventricular sense blanked out the right atrial (ra) beat.The ventricle became greater than atrium and anti-tachycardia pacing (atp) was inappropriately delivered.Technical services (ts) provided programming optimization and while reviewing observed some previous false atrial tachy response (atr) episodes with noise on both the ra and shock channels, with oversensing only on the ra.This icd remains in service at this time.No adverse patient effects were reported.Additional information was received from the field that the physician requested to increase the lowest tachy therapy zone to prevent further inappropriate atp.The physician and patient are discussing device replacement options with no date set.No adverse patient effects were reported.This icd remains in service.
Additional Manufacturer Narrative
Additional information received from the field for b5 and e1: initial reporter email fields.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of 'cause linked to device but unable to trace more specifically'.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of oversensing was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1003, which states that the voltage is too low for projected remaining capacity.A request was made to have data from this device analyzed.Data analysis showed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.Additionally, this patient experienced an episode in which 1 early ventricular sense blanked out the right atrial (ra) beat.The ventricle became greater than atrium and anti-tachycardia pacing (atp) was inappropriately delivered.Technical services (ts) provided programming optimization and while reviewing observed some previous false atrial tachy response (atr) episodes with noise on both the ra and shock channels, with oversensing only on the ra.This icd remains in service at this time.No adverse patient effects were reported.Additional information was received from the field that the physician requested to increase the lowest tachy therapy zone to prevent further inappropriate atp.The physician and patient discussed device replacement options with no date set.No adverse patient effects were reported.This icd remains in service.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.The device was not returned for analysis; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause linked to device but unable to trace more specifically.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1003, which states that the voltage is too low for projected remaining capacity.A request was made to have data from this device analyzed.Data analysis showed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.Additionally, this patient experienced an episode in which 1 early ventricular sense blanked out the right atrial (ra) beat.The ventricle became greater than atrium and anti-tachycardia pacing (atp) was inappropriately delivered.Technical services (ts) provided programming optimization and while reviewing observed some previous false atrial tachy response (atr) episodes with noise on both the ra and shock channels, with oversensing only on the ra.This icd remains in service at this time.No adverse patient effects were reported.Additional information was received from the field that the physician requested to increase the lowest tachy therapy zone to prevent further inappropriate atp.The physician and patient discussed device replacement options with no date set.No adverse patient effects were reported.This icd remains in service.The device was not returned for analysis; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of 'cause linked to device but unable to trace more specifically'.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of oversensing was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Additional information was received that this icd was explanted and replaced.No additional adverse patient effects were reported.This icd is no longer in service.

• Brand Name: PERCIVA? ICD DR
• 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: 24280162
• Report Number: 2124215-2026-06893
• Device Sequence Number: 15517358
• Product Code: LWS
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/04/2026

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: 01/31/2022
• Device Model Number: D401
• Device Catalogue Number: D401
• Device Lot Number: 253557
• Was Device Available for Evaluation?: No
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 02/06/2026; 04/15/2026; 06/02/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 02/06/2026; 04/17/2026; 06/04/2026
• 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: 55 YR
• Patient Sex: Male