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

Model Number	E051
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this pacemaker exhibited right ventricular (rv) high out of range pacing impedance measurements greater than 2000 ohms.Technical services (ts) was consulted, discussed one non-sustained ventricular tachycardia (nsvt) episode that had noise that was oversensed.Technical services (ts) options for trouble shooting to determine if it is a spring contact anomaly or lead fracture.This pacemaker system remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker exhibited right ventricular (rv) high out of range pacing impedance measurements greater than 2000 ohms.Technical services (ts) was consulted, discussed one non-sustained ventricular tachycardia (nsvt) episode that had noise that was oversensed.Technical services (ts) options for trouble shooting to determine if it is a spring contact anomaly or lead fracture.This pacemaker system remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent fluctuations in impedance measurements with no conclusive evidence of a product performance issue; please refer to the description for more information regarding the specific circumstances of this event.

• Brand Name: PUNCTUA? ICD
• 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: 22006717
• Report Number: 2124215-2025-30509
• Device Sequence Number: 7238070
• Product Code: LWP
• UDI-Device Identifier: 00802526480683
• UDI-Public: (01)00802526480683(17)141115
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: 11/15/2014
• Device Model Number: E051
• Device Catalogue Number: E051
• Device Lot Number: 100723
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/25/2025
• Date Device Manufactured: 11/21/2012
• 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: Male