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

Model Number	N051
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further information is available at this time.This report will be updated should further information become available.
Event or Problem Description
It was reported that this device exhibited premature battery depletion consistent with that of a fault code 1003.Data analysis was completed and device replacement was recommended.This device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product has been returned for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
It was reported that this device exhibited premature battery depletion consistent with that of a fault code 1003.Data analysis was completed and device replacement was recommended.This device was then explanted and replaced.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this device exhibited premature battery depletion consistent with that of a fault code 1003.Data analysis was completed and device replacement was recommended.This device was then explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The returned cardiac resynchronization therapy defibrillator (crt-d) 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's battery.Low voltage capacitors are used in the device's 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 this device's battery faster than normal.Boston scientific has issued an advisory communication regarding an older subset of cognis/teligen devices that is more susceptible to this anomaly.Specifically, the performance of a low voltage capacitor may be compromised over time, causing an increased current drain that can lead to premature battery depletion.This particular device was not included in the advisory population.

• Brand Name: PUNCTUA CRT-D
• Common Device Name: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10236818
• Report Number: 2124215-2020-12730
• Device Sequence Number: 536008
• Product Code: LWP
• UDI-Device Identifier: 00802526480928
• UDI-Public: 00802526480928
• Combination Product (Y/N): N
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2020

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: 03/28/2013
• Device Model Number: N051
• Device Catalogue Number: N051
• Device Lot Number: 100808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 06/26/2020; 09/16/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 07/28/2020; 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR