MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTIO; IMPLANTABLE PACEMAKER

Model Number	K063
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this pacemaker exhibited a high out of range pacing impedance measurement on the right ventricular (rv) lead channel that triggered a red call doctor (rcd) on the communicator.The measurement suddenly dropped to within limits value and has remained stable since.The device remains in use.No adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker exhibited a high out of range pacing impedance measurement on the right ventricular (rv) lead channel that triggered a red call doctor (rcd) on the communicator.The measurement suddenly dropped to within limits value and has remained stable since.The device remains in use.No adverse patient effects were reported.

• Brand Name: ADVANTIO
• 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: 19907818
• Report Number: 2124215-2024-48267
• Device Sequence Number: 15641343
• Product Code: LWP
• UDI-Device Identifier: 00802526516702
• UDI-Public: 00802526516702
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

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: 09/04/2016
• Device Model Number: K063
• Device Catalogue Number: K063
• Device Lot Number: 154507
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 08/12/2024
• Date Device Manufactured: 09/11/2014
• 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: Male