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

Model Number	S602
Medical Device Problem Codes	Difficult to Remove (1528); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this pacemaker system was scheduled for a routine battery replacement procedure.After unscrewing the setscrews from the right atrial (ra) port, the terminal pin remained in the header and separated from the lead body upon attempting to disconnect the ra lead.The ra lead fractured, and the conductor wires came undone.The pacemaker and ra terminal pin in the header were explanted, and the decision was made to cut the exposed wiring and surgically abandon the ra lead.The new pacemaker and a new ra lead were successfully implanted.No additional adverse patient effects were reported.Product return was requested.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing/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.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that this pacemaker system was scheduled for a routine battery replacement procedure.After unscrewing the setscrews from the right atrial (ra) port, the terminal pin remained in the header and separated from the lead body upon attempting to disconnect the ra lead.The ra lead fractured, and the conductor wires came undone.The pacemaker and ra terminal pin in the header were explanted, and the decision was made to cut the exposed wiring and surgically abandon the ra lead.The new pacemaker and a new ra lead were successfully implanted.No additional adverse patient effects were reported.Product return was requested.

• 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: 20164314
• Report Number: 2124215-2024-55915
• Device Sequence Number: 15282027
• Product Code: LWP
• UDI-Device Identifier: 00802526484476
• UDI-Public: (01)00802526484476(17)150930(21)786352
• 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: 2013
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: S602
• Device Catalogue Number: S602
• Device Lot Number: 786352
• 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: 08/09/2024
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2013
• 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: 63 YR
• Patient Sex: Male