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

Model Number	N051
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); No Code Available (3191)
Date of Event	10/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) showed 3.5 years remaining in battery life but last year it showed 6 years.Boston scientific technical services (ts) noted that the programmed outputs were nominal.Ts noted that the patient was in atrial fibrillation (af) and there were thousands of atrial tachy response (atr)s observed.Ts discussed that because of the af, the atrial sense amplifiers are on all of the time and could impact longevity.Furthermore, ts also stated that there have been several yellow alert transmissions which could also impact the longevity.The device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
The returned cardiac resynchronization therapy defibrillator (crt-d) was analyzed.The elective replacement indicator (eri) to end of life (eol) window was found to be shorter than expected, but full device function was verified.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 resulted in a shortened eri to eol window.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
Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) showed 3.5 years remaining in battery life but last year it showed 6 years.Boston scientific technical services (ts) noted that the programmed outputs were nominal.Ts noted that the patient was in atrial fibrillation (af) and there were thousands of atrial tachy response (atr)s observed.Ts discussed that because of the af, the atrial sense amplifiers are on all of the time and could impact longevity.Furthermore, ts also stated that there have been several yellow alert transmissions which could also impact the longevity.This device was explanted.No additional adverse patient effects were reported.This device was returned for analysis.Device analysis determined that the device failed labeled longevity calculation.There were no other suspicious faults or resets noted.The daily battery voltage measurements displayed a pattern of steady and rapid discharge.

• 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: 8314557
• Report Number: 2124215-2018-64292
• Device Sequence Number: 18848532
• Product Code: LWP
• UDI-Device Identifier: 00802526480928
• UDI-Public: 00802526480928
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2020

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: 03/23/2013
• Device Model Number: N051
• Device Catalogue Number: N051
• Device Lot Number: 100677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 11/01/2020
• 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: Required Intervention
• Patient Age: 61 YR