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

Model Number	S606
Medical Device Problem Codes	Failure to Capture (1081); Pacing Problem (1439)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that the patient with this pacemaker had a cardioversion.Subsequently, atrial and ventricular pacing was noted on the programmer post; however, the patient was in asystole; therefore, the clinical representative suggested a possible loss of capture (loc).As a result, this pacemaker was explanted and successfully replaced.No additional adverse patient effects were reported.At this time, this device has not been returned to boston scientific for further analysis.
Event or Problem Description
It was reported that the patient with this pacemaker had a cardioversion.Subsequently, atrial and ventricular pacing was noted on the programmer; however, the patient was in asystole, therefore, the clinical representative suggested a possible loss of capture (loc).As a result, this pacemaker was explanted and successfully replaced.No additional adverse patient effects were reported.At this time, this device has not been returned to boston scientific for further analysis.Additional information indicated that during the previously mentioned interrogation, it was observed that device had a low battery due to normal battery depletion.The clinical representative suspected that the interrogation caused a drop in the remaining battery, leading to pacing inhibition.No additional adverse patient effects were reported.At this time, this device has not been returned to boston scientific for further analysis.
Additional Manufacturer Narrative
Follow up report 1 (additional information): this report is being submitted to update section b.5 and h.6 device and impact codes.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that the patient with this pacemaker had a cardioversion.Subsequently, atrial and ventricular pacing was noted on the programmer; however, the patient was in asystole, therefore, the clinical representative suggested a possible loss of capture (loc).As a result, this pacemaker was explanted and successfully replaced.No additional adverse patient effects were reported.At this time, this device has not been returned to boston scientific for further analysis.Additional information indicated that during the previously mentioned interrogation, it was observed that device had a low battery due to normal battery depletion.The clinical representative suspected that the interrogation caused a drop in the remaining battery, leading to pacing inhibition.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Follow up report 1 (additional information): this report is being submitted to update section b.5 and h.6 device and impact codes.At this time, no further information is available.Should additional information become available this report will be updated.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was exposed to simulated heart load conditions, and the pacing and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Review of device memory noted that battery replacement indicator had not been reached prior to device explant and evidence indicated the battery was lasting as long as expected.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• 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: 21777944
• Report Number: 2124215-2025-21036
• Device Sequence Number: 12686726
• Product Code: LWP
• UDI-Device Identifier: 00802526484490
• UDI-Public: (01)00802526484490(17)120805
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2025

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: 08/05/2012
• Device Model Number: S606
• Device Catalogue Number: S606
• Device Lot Number: 141403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 04/03/2025; 06/12/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/11/2025; 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2010
• 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: 83 YR
• Patient Sex: Male