MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 20; IMPLANTABLE PACEMAKER

Model Number	S208
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that battery status indicators were different than expected based on information provided to boston scientific.Factors influencing the estimated longevity remaining calculation include pacing rate, amplitude, pulse-width and lead impedance.Any changes in these factors will impact the battery consumption calculation and therefore the remaining longevity estimate.Please refer to the description for more information regarding the specific circumstances of this event.Please note this pacemaker's battery was designed to estimate remaining longevity based on the pacing capacitor charge time, which progressively increases as the battery depletes.These pacemakers were not designed with an ability to calculate remaining longevity for every possible current drain, which may cause replacement indicators to trigger earlier than what was previously estimated; however, it does not negatively impact the use, operation, safety, or performance of the device.
Event or Problem Description
It was reported that this pacemaker had less than six months remaining with magnet rate of ninety beats per minute.Atrial lead was then turned off for chronic atrial fibrillation (af).Boston scientific technical services (ts) discussed that it sounded like it should go back to a hundred beats per minute.This device remained at ninety beats per minute post programming.It was then recommended to recheck the device to see the resulting longevity projection and magnet rate.Moreover, the associated investigation determined that the battery status indicators were different than expected.To date, this device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that battery status indicators were different than expected based on information provided to boston scientific.Factors influencing the estimated longevity remaining calculation include pacing rate, amplitude, pulse-width and lead impedance.Any changes in these factors will impact the battery consumption calculation and therefore the remaining longevity estimate.Please refer to the description for more information regarding the specific circumstances of this event.Please note this pacemaker's battery was designed to estimate remaining longevity based on the pacing capacitor charge time, which progressively increases as the battery depletes.These pacemakers were not designed with an ability to calculate remaining longevity for every possible current drain, which may cause replacement indicators to trigger earlier than what was previously estimated; however, it does not negatively impact the use, operation, safety, or performance of the device.The product has been received for analysis.Upon completion of the failure analysis of the complaint product, if there is any further relevant information from that review, a supplemental report will be filed.
Event or Problem Description
It was reported that this pacemaker had less than six months remaining with magnet rate of ninety beats per minute.Atrial lead was then turned off for chronic atrial fibrillation (af).Boston scientific technical services (ts) discussed that it sounded like it should go back to a hundred beats per minute.This device remained at ninety beats per minute post programming.It was then recommended to recheck the device to see the resulting longevity projection and magnet rate.Moreover, the associated investigation determined that the battery status indicators were different than expected.To date, this device remains in service.No adverse patient effects were reported.Additional information received indicates that the device was explanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that battery status indicators were different than expected based on information provided to boston scientific.Factors influencing the estimated longevity remaining calculation include pacing rate, amplitude, pulse-width and lead impedance.Any changes in these factors will impact the battery consumption calculation and therefore the remaining longevity estimate.Please refer to the description for more information regarding the specific circumstances of this event.Please note this pacemaker's battery was designed to estimate remaining longevity based on the pacing capacitor charge time, which progressively increases as the battery depletes.These pacemakers were not designed with an ability to calculate remaining longevity for every possible current drain, which may cause replacement indicators to trigger earlier than what was previously estimated; however, it does not negatively impact the use, operation, safety, or performance of the device.The product has been received for analysis.Upon completion of the failure analysis of the complaint product, if there is any further relevant information from that review, a supplemental report will be filed.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.<
Event or Problem Description
It was reported that this pacemaker had less than six months remaining with magnet rate of ninety beats per minute.Atrial lead was then turned off for chronic atrial fibrillation (af).Boston scientific technical services (ts) discussed that it sounded like it should go back to a hundred beats per minute.This device remained at ninety beats per minute post programming.It was then recommended to recheck the device to see the resulting longevity projection and magnet rate.Moreover, the associated investigation determined that the battery status indicators were different than expected.To date, this device remains in service.No adverse patient effects were reported.Additional information received indicates that the device was explanted.No additional adverse patient effects were reported.

• Brand Name: ALTRUA 20
• Common Device Name: IMPLANTABLE PACEMAKER
• 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: 11181983
• Report Number: 2124215-2020-28078
• Device Sequence Number: 14433200
• Product Code: LWP
• UDI-Device Identifier: 00802526484421
• UDI-Public: 00802526484421
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2024
• 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): 07/16/2024

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: 07/13/2012
• Device Model Number: S208
• Device Catalogue Number: S208
• Device Lot Number: 594833
• 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: 11/03/2020
• Supplement Date Received by Manufacturer: 02/19/2024; 06/28/2024
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 03/04/2024; 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2010
• 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: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male