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

Model Number	S205
Medical Device Problem Code	Telemetry Discrepancy (1629)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this pacemaker could not be interrogated by different programmers.Different troubleshooting options were discussed with the different programmers and still the device could not be interrogated.An x ray was completed to confirm the device was still implanted.It was recommended to consider the patient unprotected and replace device.The pacemaker remains in service at this time.No adverse patient effects were reported.

• Brand Name: ALTRUA 20
• Common Device Name: IMPLANTABLE 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: 20436512
• Report Number: 2124215-2024-63906
• Device Sequence Number: 8343397
• Product Code: LWP
• UDI-Device Identifier: 00802526499210
• UDI-Public: 00802526499210
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2024

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: 04/24/2015
• Device Model Number: S205
• Device Catalogue Number: S205
• Device Lot Number: 569380
• 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: 09/16/2024
• Initial Report FDA Received Date: 10/13/2024
• Date Device Manufactured: 05/08/2013
• 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
• Patient Sex: Female