MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 40; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	S404
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
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.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 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 implantable pacemaker had longevity of six months dropped to end of life (eol) in a span of four months.Boston scientific technical services (ts) discussed how the device manages longevity in relation to current bins and could have been this device was operating in a lower current but on the edge of it.Also, some small change in the variables that impact longevity causing the device to operate in a higher current bin pushing the device to eri.This device will be changed out.Additional information indicated that this device was explanted.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable pacemaker had longevity of six months dropped to end of life (eol) in a span of four months.Boston scientific technical services (ts) discussed how the device manages longevity in relation to current bins and could have been this device was operating in a lower current but on the edge of it.Also, some small change in the variables that impact longevity causing the device to operate in a higher current bin pushing the device to eri.This device will be changed out.Additional information indicated that this device was explanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.Detailed analysis did not confirm gas gauge/longevity not as expected allegation based on review of the device memory noted no resets, errors, or fault codes further, no problem detected was selected based on analysis of the returned product.Analysis found no evidence of device defect or anomaly outside the bounds of normal medical use.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 description 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.

• Brand Name: ALTRUA 40
• 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: 17434708
• Report Number: 2124215-2023-40672
• Device Sequence Number: 15688975
• Product Code: LWP
• UDI-Device Identifier: 00802526484452
• UDI-Public: 00802526484452
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

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: 09/28/2013
• Device Model Number: S404
• Device Catalogue Number: S404
• Device Lot Number: 599033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2011
• 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: 74 YR
• Patient Sex: Female