MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 60; IMPLANTABLE DEVICE

Model Number	S602
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implanted pacemaker and right ventricular (rv) lead were replaced due to an unspecified issue.The rv lead was capped and remains in the patient.No additional adverse patient effects were reported.Additional information is being requested at this time.
Event or Problem Description
It was reported that the implanted pacemaker and right ventricular (rv) lead were replaced due to an unspecified issue.The rv lead was capped and remains in the patient.No additional adverse patient effects were reported.Additional information is being requested at this time.Additional information received indicated that the lead was replaced due to a high threshold (2.6 v at 1.0 ms).Initially, the capture threshold wasn't an issue for therapy; however, over time the patient needed a higher percentage of pacing.The pacemaker was electively replaced due to approaching end-of-life.No additional adverse patient effects were reported.

• Brand Name: ALTRUA 60
• Common Device Name: IMPLANTABLE DEVICE
• 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: 16417915
• Report Number: 2124215-2023-08202
• Device Sequence Number: 5363035
• Product Code: LWP
• UDI-Device Identifier: 00802526484476
• UDI-Public: 00802526484476
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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: 06/19/2014
• Device Model Number: S602
• Device Catalogue Number: S602
• Device Lot Number: 783296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2012
• 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: Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female