MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PUNCTUA CRT-D; IMPLANTABLE DEVICE

Model Number	N051
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) went to elective replacement indicator (eri) so quickly.The battery of this crt-d was at seven months last february and now reached eri.Boston scientific technical services (ts) discussed that it looks like charge time was greater than fifteen seconds and so eri was tripped.Ts offered additional analysis, but the field representative declined.To date, 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.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 cardiac resynchronization therapy defibrillator (crt-d) went to elective replacement indicator (eri) so quickly.The battery of this crt-d was at seven months last february and now reached eri.Boston scientific technical services (ts) discussed that it looks like charge time was greater than fifteen seconds and so eri was tripped.Ts offered additional analysis, but the field representative declined.To date, the device remains in service.No adverse patient effects were reported.Additional information received indicated that this device was explanted, and a new device was replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.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 of cardiac resynchronization therapy defibrillator (crt-d) device was analyzed and an engineering-level longevity prediction calculation was completed to assess the rate of battery depletion.Given the programmed parameters and other data stored within the memory of the device, the results of this calculation indicated that the actual rate of battery depletion fell within an acceptable range.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing, defibrillation, and recording functions.Having met the engineering longevity prediction, functionally passed all returned product testing, and with no further information to indicate a product performance issue, we have concluded that this device experienced normal battery depletion.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) went to elective replacement indicator (eri) so quickly.The battery of this crt-d was at seven months last february and now reached eri.Boston scientific technical services (ts) discussed that it looks like charge time was greater than fifteen seconds and so eri was tripped.Ts offered additional analysis, but the field representative declined.To date, the device remains in service.No adverse patient effects were reported.Additional information received indicated that this device was explanted, and a new device was replaced.No additional adverse patient effects were reported.

• Brand Name: PUNCTUA CRT-D
• Common Device Name: IMPLANTABLE DEVICE
• 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: 16709308
• Report Number: 2124215-2023-16647
• Device Sequence Number: 20673216
• Product Code: LWP
• UDI-Device Identifier: 00802526480928
• UDI-Public: 00802526480928
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• 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): 11/27/2023

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: 09/27/2013
• Device Model Number: N051
• Device Catalogue Number: N051
• Device Lot Number: 100705
• 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: 03/27/2023
• Supplement Date Received by Manufacturer: 04/19/2023; 11/16/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/11/2023; 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2012
• 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: 75 YR
• Patient Sex: Male