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

Model Number	S606
Medical Device Problem Codes	Premature Discharge of Battery (1057); Battery Problem (2885); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem.This investigation will be updated should pertinent information become available in the future.
Event or Problem Description
It was reported that this pacemaker delivered 11 atrial tachy response (atr) episodes but only two were recorded on the logbook.In addition, it was mentioned that over the last months the battery longevity time has decreased from two years to less than six months remaining.Technical services (ts) was consulted and upon data review discussed with the health care professional (hcp) the possibility that the wrong time and date settings were selected during the resynchronization of the device.Ts instructed the hcp to restart the logbook and recommended normal device follow up and monitoring.This pacemaker remains in service.No adverse patient effects were reported.Additional information was received, ts discussed that the device has exceeded longevity expectation.This pacemaker remains in service.No adverse patient effects were reported.This product remains in service and has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Based on a thorough review of the reported complaint, the conclusion code unable to exclude device problem was assigned.Additional information was received; this pacemaker was explanted and replaced and has not been returned for analysis.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker delivered 11 atrial tachy response (atr) episodes but only two were recorded on the logbook.In addition, it was mentioned that over the last months the battery longevity time has decreased from two years to less than six months remaining.Technical services (ts) was consulted and upon data review discussed with the health care professional (hcp) the possibility that the wrong time and date settings were selected during the resynchronization of the device.Ts instructed the hcp to restart the logbook and recommended normal device follow up and monitoring.This pacemaker remains in service.No adverse patient effects were reported.Additional information was received, ts discussed that the device has exceeded longevity expectation.This pacemaker remains in service.No adverse patient effects were reported.This product remains in service and has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Based on a thorough review of the reported complaint, the conclusion code unable to exclude device problem was assigned.Additional information was received; this pacemaker was explanted and replace and has not been returned for analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, product analysis could not be conducted.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance with labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.A risk review was completed and confirmed that the event of data issue was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.

• Brand Name: ALTRUA? 60
• Common Device Name: 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: 24747659
• Report Number: 2124215-2026-17697
• Device Sequence Number: 8708026
• Product Code: LWP
• UDI-Device Identifier: 00802526484490
• UDI-Public: (01)00802526484490(17)120209
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2026
• 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): 06/16/2026

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: 02/09/2012
• Device Model Number: S606
• Device Catalogue Number: S606
• Device Lot Number: 129948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 06/16/2026
• Date Device Manufactured: 02/11/2010
• 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: 35 YR
• Patient Sex: Female