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

Model Number	E051
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Also, the device was found at battery capacity depleted (bcd) after the recorded code 1003.Boston scientific technical services (ts) recommended device replacement as soon as possible.As of this time, the device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Also, the device was found at battery capacity depleted (bcd) after the recorded code 1003.Boston scientific technical services (ts) recommended device replacement as soon as possible.This icd was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A review of low voltage was recorded.No other suspicious faults or resets were noted.Based on the memory log the device battery voltage was greater than 2.7 volts and the power usage was normal while implanted, all therapy was available while implanted.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Also, the device was found at battery capacity depleted (bcd) after the recorded code 1003.Boston scientific technical services (ts) recommended device replacement as soon as possible.This icd was explanted and replaced.No additional adverse patient effects were reported.

• 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: 18895117
• Report Number: 2124215-2024-15217
• Device Sequence Number: 6152905
• Product Code: LWP
• UDI-Device Identifier: 00802526480683
• UDI-Public: 00802526480683
• 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: 2013
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2025

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: 11/08/2014
• Device Model Number: E051
• Device Catalogue Number: E051
• Device Lot Number: 100686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 10/25/2024; 12/19/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 11/21/2024; 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2012
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male