MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 20; PACEMAKER

Model Number	S203
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable device exhibited high out-of-range pacing impedance measurements.Six months ago, this device reached an elective replacement indicator (eri).The patient is not dependent.Additionally, intermittently signals oversensed and undersensed were observed on the right atrial (ra) lead.An interrogation was tried performed.However; this device was unable to be interrogated.Troubleshooting efforts were performed.It was determined that the right ventricular (rv) lead exhibited high impedance measurements and the ra lead exhibited high out-of-range pacing impedance measurements.Loss of capture was also seen on the ra channel.Leads replacement was recommended.No adverse patient effects were reported.

• Brand Name: ALTRUA 20
• 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: 15108755
• Report Number: 2124215-2022-27589
• Device Sequence Number: 4587779
• Product Code: LWP
• UDI-Device Identifier: 00802526484391
• UDI-Public: 00802526484391
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S096
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2022

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: 11/22/2012
• Device Model Number: S203
• Device Catalogue Number: S203
• Device Lot Number: 715749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2010
• 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: 75 YR
• Patient Sex: Female