MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

Model Number	V173
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited far-field oversensing in the right atrial (ra) channel.Which resulted in inappropriate atrial tachy response (atr) episodes to be stored.Reprogramming options and sensitivity adjustments were performed.Subsequently, the left ventricular (lv) activity started to be sensed on the ra channel.Ts recommended turning off the lv sensitivity, but it remained at the physician discretion.In addition, this crt-p system presented high out of range pacing impedance measurements with high pacing thresholds.This crt-p remains in service.No adverse patient effects were reported.

• Brand Name: INVIVE
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY 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: 20654091
• Report Number: 2124215-2024-70760
• Device Sequence Number: 8218659
• Product Code: NKE
• UDI-Device Identifier: 00802526536632
• UDI-Public: 00802526536632
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P030005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2024

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: 06/06/2016
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 106556
• 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: 10/21/2024
• Initial Report FDA Received Date: 11/11/2024
• Date Device Manufactured: 06/17/2014
• 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: 84 YR
• Patient Sex: Male