MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

Model Number U128

Device Problem High impedance (1291)

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

Event Date 08/01/2021

Event Type  malfunction  

Manufacturer Narrative

This investigation will be updated should further pertinent information be provided.

Event Description

It was reported that this system with a cardiac resynchronization therapy pacemaker (crt-p) and a non bsc right ventricular (rv) lead has been showing high, out of range pacing impedances over the last year.No noise was reproducible in the configuration it is.The crt-p and the rv lead remain in service at this time.According to the field representative, no corrective actions have been completed at this time.Patient will follow up with electrophysiologist as scheduled.No adverse patient effects were reported.

• Brand Name: VALITUDE X4 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: 14107371
• MDR Text Key: 289263014
• Report Number: 2124215-2022-10582
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• 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: Other
• Type of Report: Initial
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2019
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 717462
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2017
• 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: 80 YR
• Patient Sex: Male