MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 60; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	S602
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2022
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 section for more information regarding the specific circumstances of this event.Please note this pacemakers 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 there were concerns regarding alleged premature battery depletion of this pacemaker.At the most recent follow-up, six months prior, the longevity remaining was about 2.5 years.At the latest clinic appointment, the device had met end of life since 30apr2022.Data was provided for analysis and boston scientific technical services indicated that the device is functioning normally.This device has been implanted over 11 years which is over the estimated battery life.The plan is to replace this device.No adverse patient effects were reported.At this time, this device remains implanted.
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 section b5 for more information regarding the specific circumstances of this event.Please note this pacemakers 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 there were concerns regarding alleged premature battery depletion of this pacemaker.At the most recent follow-up, six months prior, the longevity remaining was about 2.5 years.At the latest clinic appointment, the device had met end of life since 30apr2022.Data was provided for analysis and boston scientific technical services indicated that the device is functioning normally.This device has been implanted over 11 years which is over the estimated battery life.The plan is to replace this device.Subsequently, this device was explanted and replaced with a competitor device.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that there were concerns regarding alleged premature battery depletion of this pacemaker.At the most recent follow-up, six months prior, the longevity remaining was about 2.5 years.At the latest clinic appointment, the device had met end of life since 30apr2022.Data was provided for analysis and boston scientific technical services indicated that the device is functioning normally.This device has been implanted over 11 years which is over the estimated battery life.The plan is to replace this device.Subsequently, this device was explanted and replaced with a competitor device.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, detailed mechanical and electrical testing was performed on the device.The device battery status was eol.The device functioned normally throughout testing.Laboratory analysis determined that this device experienced normal battery depletion; however, the estimated longevity remaining value appeared to decrease more quickly than expected between routine follow-ups.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.In summary, it was determined that this device experienced normal battery depletion, but declared eol earlier than previously estimated.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.

• Brand Name: ALTRUA 60
• 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: 14732277
• Report Number: 2124215-2022-21863
• Device Sequence Number: 17592481
• Product Code: LWP
• UDI-Device Identifier: 00802526484476
• UDI-Public: 00802526484476
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2023

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: 07/01/2012
• Device Model Number: S602
• Device Catalogue Number: S602
• Device Lot Number: 767053
• 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: 06/10/2022
• Supplement Date Received by Manufacturer: 06/20/2022; 04/06/2023
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 06/22/2022; 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown