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

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	04/18/2024
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 device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis showed that the low voltage fault was appropriate.The device hardware is not detecting the loss of battery energy.Because of this, the battery status indicators are not reflecting the depletion condition and are inaccurate and should no longer be relied upon to determine the depletion status of the device.A device replacement was recommended.The device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.The device has been received for analysis and upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a medwatch report will be filed.
Event or Problem Description
It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis showed that the low voltage fault was appropriate.The device hardware is not detecting the loss of battery energy.Because of this, the battery status indicators are not reflecting the depletion condition and are inaccurate and should no longer be relied upon to determine the depletion status of the device.A device replacement was recommended.The device remains in service.No adverse patient effects were reported.Additional information was received indicating that the device was explanted and was returned for further analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.The device has been received for analysis and upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a medwatch report will be filed.Upon receipt at our post market quality assurance laboratory, the battery run down curve is consistent with normal depletion devices.Normal battery run down was noted without any other symptoms.Reviewed memory log indicated that while implanted, the device recorded a low voltage fault.No other suspicious faults or resets were noted.The daily battery voltage measurements displayed a pattern of steady and rapid discharge.The device diagnostic data spreadsheet graph shows a cell depletion pattern that is consistent with normal battery depletion.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.Based on the battery depletion curves (no indications of intermittency) and no faults other than fc1003.This is consistent with normal battery depletion.No further investigation is required.
Event or Problem Description
It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis showed that the low voltage fault was appropriate.The device hardware is not detecting the loss of battery energy.Because of this, the battery status indicators are not reflecting the depletion condition and are inaccurate and should no longer be relied upon to determine the depletion status of the device.A device replacement was recommended.The device remains in service.No adverse patient effects were reported.Additional information was received indicating that the device was explanted and was returned for further analysis.No additional adverse patient effects were reported.

• 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: 19183659
• Report Number: 2124215-2024-25126
• Device Sequence Number: 7412457
• Product Code: LWP
• UDI-Device Identifier: 00802526480683
• UDI-Public: 00802526480683
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S235
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2024

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: 08/16/2014
• Device Model Number: E051
• Device Catalogue Number: E051
• Device Lot Number: 100477
• 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: 04/18/2024
• Supplement Date Received by Manufacturer: 05/09/2024; 06/11/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/15/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2012
• 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: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male