MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PUNCTUA? ICD; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	E052
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) oversensed noise, which resulted in inappropriate atrial tachy response (atr) and ventricular arrhythmia episodes.Technical services (ts) reviewed the events and indicated the noise appeared to be from electrocautery.The health care professional (hcp) confirmed the stored events occurred during a medical procedure.No adverse patient effects were reported.This icd remains in service.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) oversensed noise, which resulted in inappropriate atrial tachy response (atr) and ventricular arrhythmia episodes.Technical services (ts) reviewed the events and indicated the noise appeared to be from electrocautery.The health care professional (hcp) confirmed the stored events occurred during a medical procedure.No adverse patient effects were reported.This icd remains in service.Additional information was received that this icd stored episodes containing noise artifact following a surgical procedure in which a magnet was placed on the device.Ts reviewed presenting device data and determined that the device was operating as programmed.No adverse patient effects were reported.This icd remains in service.
Additional Manufacturer Narrative
This icd was thoroughly inspected and analyzed upon receipt.Baseline testing found no failing conditions and the device passed all other testing.Additionally, visual inspection found no anomalies.Analysis found no evidence of device defect outside the bounds of normal medical use.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) oversensed noise, which resulted in inappropriate atrial tachy response (atr) and ventricular arrhythmia episodes.Technical services (ts) reviewed the events and indicated the noise appeared to be from electrocautery.The health care professional (hcp) confirmed the stored events occurred during a medical procedure.No adverse patient effects were reported.This icd remains in service.Additional information was received that this icd stored episodes containing noise artifact following a surgical procedure in which a magnet was placed on the device.Ts reviewed presenting device data and determined that the device was operating as programmed.No adverse patient effects were reported.This icd remains in service.Additionally, this icd was explanted and replaced due to normal battery depletion.This device has been received.Other than the surgical procedure, no additional adverse patient effects were reported.

• Brand Name: PUNCTUA? ICD
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 19809215
• Report Number: 2124215-2024-45552
• Device Sequence Number: 20908666
• Product Code: LWP
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• 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,Followup,Followup
• Report Date (Section B): 01/05/2026

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: 10/31/2015
• Device Model Number: E052
• Device Catalogue Number: E052
• Device Lot Number: 100308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 08/29/2024; 12/31/2025
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 09/09/2024; 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2013
• 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: 70 YR
• Patient Sex: Male