MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 60; IMPLANTABLE PACEMAKER DEVICE

Model Number	S603
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker battery was at less than half a year.Boston scientific technical services (ts) suggested to look back to see if health care professional (hcp) can determine when the first the magnet rate was noted and will be about one year from that time frame that device will reach elective replacement indicator (eri).The device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.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 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.
Additional Manufacturer Narrative
The returned implantable pacemaker was analyzed and an engineering-level longevity prediction calculation was completed to assess the rate of battery depletion.Given the programmed parameters and other data stored within the memory of the device, the results of this calculation indicated that the actual rate of battery depletion fell within an acceptable range.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing, and recording functions.Having met the engineering longevity prediction, functionally passed all returned product testing, and with no further information to indicate a product performance issue, we have concluded that this device experienced normal battery depletion.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 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 this pacemaker battery was at less than half a year.Boston scientific technical services (ts) suggested to look back to see if health care professional (hcp) can determine when the first the magnet rate was noted and will be about one year from that time frame that device will reach elective replacement indicator (eri).Additional information was received indicating that this device was electively explanted due to normal battery depletion (nbd) and a new device was placed.No adverse patient effects were reported.Additional information received indicating that this device was explanted.No additional adverse patient effects were reported.

• Brand Name: ALTRUA 60
• Common Device Name: IMPLANTABLE PACEMAKER DEVICE
• 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: 15581336
• Report Number: 2124215-2022-40855
• Device Sequence Number: 20450739
• Product Code: LWP
• UDI-Device Identifier: 00802526484483
• UDI-Public: 00802526484483
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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: 03/27/2014
• Device Model Number: S603
• Device Catalogue Number: S603
• Device Lot Number: 956532
• 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: 10/03/2022
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2012
• 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: 53 YR
• Patient Sex: Male