MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 20; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	S201
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
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 even slight changes in these factors will impact the battery consumption calculation and therefore the remaining longevity estimate.Describe event or problem for more information regarding the specific circumstances of this event.Please note this pacemaker's battery was designed to estimate remaining longevity and trigger corresponding device replacement indicators 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 half a year longevity remaining but now showed two years longevity.Boston scientific technical services (ts) discussed current bins causing change in programmer estimate longevity and advised that magnet rate showed device is less than a year.To date, the 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 even slight changes in these factors will impact the battery consumption calculation and therefore the remaining longevity estimate.Please refer to the b5: describe event or problem for more information regarding the specific circumstances of this event.Please note this pacemaker's battery was designed to estimate remaining longevity and trigger corresponding device replacement indicators 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 half a year longevity remaining but now showed two years longevity.Boston scientific technical services (ts) discussed current bins causing change in programmer estimate longevity and advised that magnet rate showed device is less than a year.To date, the device remains in service.No adverse patient effects were reported.The associated investigation determined that battery status indicators were different than expected.Any changes in these factors will impact the battery consumption calculation and therefore the remaining longevity estimate.Additional information indicated that the device was explanted and was returned.
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 even slight changes in these factors will impact the battery consumption calculation and therefore the remaining longevity estimate.Please refer to the b5: describe event or problem for more information regarding the specific circumstances of this event.Please note this pacemaker's battery was designed to estimate remaining longevity and trigger corresponding device replacement indicators 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.Upon receipt at our post market quality assurance laboratory, detailed mechanical and electrical testing was performed on the device.It is suspected that the device was operating with a current drain at the bin boundary, and it is possible that the pulse generator (pg) current bin may not have matched the programmer current bin for longevity calculations.It is suspected that the device switched bins for longevity calculations.The auto-capture feature was not in use at the time of the allegation.It appears programming changes may not have been a factor, as the device was last reprogrammed nine months prior to elective replacement time (ert) declaration.Lead impedance measurements contained in the daily measurements confirm the lead impedance measurements were fairly consistent and normal.Factors influencing the estimated longevity remaining calculation include pacing rate, amplitude, pulse-width and lead impedance.Any (even slight) changes in these factors will impact the battery consumption calculation and therefore the remaining longevity estimate.Please note that, despite the drop in estimated longevity remaining, the actual battery condition did not change significantly between follow-ups.Of note, the estimated remaining battery longevity of this pacemaker was designed to be calculated (and trigger corresponding device replacement indicators) 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 half a year longevity remaining but now showed two years longevity.Boston scientific technical services (ts) discussed current bins causing change in programmer estimate longevity and advised that magnet rate showed device is less than a year.To date, the device remains in service.No adverse patient effects were reported.The associated investigation determined that battery status indicators were different than expected.Any changes in these factors will impact the battery consumption calculation and therefore the remaining longevity estimate.Additional information indicated that the device was explanted and was returned.

• Brand Name: ALTRUA 20
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 12054364
• Report Number: 2124215-2021-13305
• Device Sequence Number: 3648204
• Product Code: LWP
• UDI-Device Identifier: 00802526484384
• UDI-Public: 00802526484384
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2022

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: 04/07/2011
• Device Model Number: S201
• Device Catalogue Number: S201
• Device Lot Number: 101260
• 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: 04/07/2021
• Supplement Date Received by Manufacturer: 03/04/2022; 10/31/2022
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 04/26/2022; 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2009
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male