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

Model Number	S602
Medical Device Problem Codes	Data Problem (3196); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a clinic visit, telemetry issues was reported while interrogating this pacemaker.It was noted that during interrogation, the pacemaker displayed patient heart rate to be less than 30 beats per minute (bpm) even though markers show rate to be around 80 bpm.It was also noted that the electrogram (egm) would drop out when a threshold test was attempted.Technical services (ts) was contacted for troubleshooting assistance.Ts provided troubleshooting recommendations.At this time, this pacemaker remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
Device technical analysis: this product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Device history: 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.Labeling review: 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 to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Risk assessment: a risk review was completed and confirmed that the event of difficult to interrogate/telemetry (wand) 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.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.
Event or Problem Description
It was reported that during a clinic visit, telemetry issues was reported while interrogating this pacemaker.It was noted that during interrogation, the pacemaker displayed patient heart rate to be less than 30 beats per minute (bpm) even though markers show rate to be around 80 bpm.It was also noted that the electrogram (egm) would drop out when a threshold test was attempted.Technical services (ts) was contacted for troubleshooting assistance.Ts provided troubleshooting recommendations.At this time, this pacemaker remains in service.No adverse patient effects were reported.

• 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: 24876170
• Report Number: 2124215-2026-20123
• Device Sequence Number: 9899902
• Product Code: LWP
• UDI-Device Identifier: 00802526484476
• UDI-Public: (01)00802526484476(17)120202
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 06/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/02/2012
• Device Model Number: S602
• Device Catalogue Number: S602
• Device Lot Number: 763764
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 06/03/2026
• Date Device Manufactured: 02/04/2010
• 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
• Patient Age: 71 YR
• Patient Sex: Male