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 Code Available (3191)
Date of Event	11/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product is not expected to be returned.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further pertinent information be provided.(b)(4).
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.This device was explanted and is not expected to be returned for analysis.
Additional Manufacturer Narrative
The returned implantable pulse generator 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.Patient code 3191 captures the reportable event of surgery.
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 was not performed for this device prior to explant procedure.The device was explanted and replaced due to reported premature battery depletion and code 1003.This device was returned for analysis.The product was analyzed and the premature discharge of battery and message - error code 1003 allegations were confirmed.No other suspicious faults or resets were noted.Based on the memory log the device battery voltage and the power usage was normal while implanted, all therapy was available while implanted.

• 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: 10306133
• Report Number: 2124215-2020-14942
• Device Sequence Number: 11617161
• Product Code: LWP
• UDI-Device Identifier: 00802526480928
• UDI-Public: 00802526480928
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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: 10/03/2013
• Device Model Number: N051
• Device Catalogue Number: N051
• Device Lot Number: 100873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 10/09/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR