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

Model Number	N051
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Noise, Audible (3273)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
It was reported that the patient reported hearing tones from the cardiac resynchronization therapy defibrillator (crt-d).A remote monitoring interrogation found that the device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Device replacement was recommended.This device was explanted and returned for analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.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.Malfunction 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.
Event or Problem Description
This report is being filed to submit the analysis results.

• Brand Name: PUNCTUA CRT-D
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9548140
• Report Number: 2124215-2019-25570
• Device Sequence Number: 2426937
• 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: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2020

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: 09/23/2013
• Device Model Number: N051
• Device Catalogue Number: N051
• Device Lot Number: 100699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 01/25/2020
• 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: 83 YR