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

Model Number	S601
Medical Device Problem Code	Telemetry Discrepancy (1629)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this device was unable to be interrogated and was subsequently explanted and replaced to resolve the event.No additional adverse patient effects were reported.The device is expected to be returned for analysis, but has not yet been received.
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, 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.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 device was unable to be interrogated and was subsequently explanted and replaced to resolve the event.No additional adverse patient effects were reported.The device was received for analysis.

• 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: 15317270
• Report Number: 2124215-2022-33172
• Device Sequence Number: 5230740
• Product Code: LWP
• UDI-Device Identifier: 00802526484469
• UDI-Public: 00802526484469
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

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: 10/19/2012
• Device Model Number: S601
• Device Catalogue Number: S601
• Device Lot Number: 149851
• 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: 08/05/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown