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

Model Number	E050
Medical Device Problem Code	Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) had difficulties to interrogate.The health care professional (hcp) consulted for recommendations to interrogate this device, technical services (ts) reviewed the device data, confirmed the device is supported by the programmer and recommended to hover the wand in a circular motion.The hcp was referred to the local field representative.No adverse patient effects were reported.This icd remains in service.

• Brand Name: PUNCTUA? ICD
• 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: 24899195
• Report Number: 2124215-2026-20687
• Device Sequence Number: 13184200
• Product Code: LWP
• UDI-Device Identifier: 00802526480676
• UDI-Public: (01)00802526480676(17)150228
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: 2026
• 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): 04/16/2026

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: 02/28/2015
• Device Model Number: E050
• Device Catalogue Number: E050
• Device Lot Number: 100214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/16/2026
• Date Device Manufactured: 03/05/2013
• 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: 52 YR
• Patient Sex: Male