MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

Model Number U125

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Low impedance (2285)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2023

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) with non-bsc right atrial (ra) and right ventricular (rv) leads recorded noise over sensing on both rv and ra leads.A full in clinic check, including isometrics could not induce the noise.At an atrial tachy response event noise was also observed but the p wave was observed during that time.Also.At a ventricular event, rv noise was observed with a pause in pacing for more than two seconds, but the r wave was observed.Ra and rv impedance both have a very slight downward trend over the last year.The physician chose to reprogram the crt-p for pacing in both ra and rv channels and ra sensing was turned off.As leads have been implanted for several years, they are almost certainly experiencing some kind of degradation based on noise and impedance trends.The crtp, ra and rv leads remain in service at this time.No adverse patient effects were reported.

• Brand Name: VALITUDE CRT-P
• Type of Device: 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: 18701345
• MDR Text Key: 335293278
• Report Number: 2124215-2024-08597
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/16/2022
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 717473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Sex: Male