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

Model Number	E053
Medical Device Problem Codes	Premature Discharge of Battery (1057); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded an fc 1003 indicative of battery voltage too low for the projected remaining capacity and observed that the battery was inaccurate.Boston scientific technical services (ts) discussed that this device was not on the low voltage capacitor advisory, however, similar failure rates were noted.Ts also discussed that without analysis an emergent changeout is recommended per faults and actions.A device data for analysis was advised which could give cause and guidance for change out timing.Subsequently, this device was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.The returned implantable cardioverter defibrillator (icd) was analyzed and a review of the device memory confirmed that a low voltage alert, code 1003, was recorded.The battery voltage was lower than expected, but still supported full device function.Using historical daily battery voltage measurement data, engineers determined that this device was demonstrating behavior consistent with a high current condition associated with a compromised low voltage capacitor connected to the device battery.Low voltage capacitors are used in the high voltage charging operation in order to facilitate fast charge times.The behavior of these capacitors resulted in a high current drain, which was depleting the device battery faster than normal.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded an fc 1003 indicative of battery voltage too low for the projected remaining capacity and observed that the battery was inaccurate.Boston scientific technical services (ts) discussed that this device was not on the low voltage capacitor advisory, however, similar failure rates were noted.Ts also discussed that without analysis an emergent changeout is recommended per faults and actions.A device data for analysis was advised which could give cause and guidance for changeout timing.Subsequently, this device was explanted and replaced.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: 16076727
• Report Number: 2124215-2022-55546
• Device Sequence Number: 17682284
• Product Code: LWP
• UDI-Device Identifier: 00802526480706
• UDI-Public: 00802526480706
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 02/17/2023

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: 10/01/2015
• Device Model Number: E053
• Device Catalogue Number: E053
• Device Lot Number: 101192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 12/30/2022
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2013
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male