MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number U128

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Failure to Sense (1559)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2019

Event Type  malfunction  

Event Description

It was reported that during the implant procedure this cardiac resynchronization therapy pacemaker (crt-p) system exhibited no sensing and high out of range pacing impedances on the left ventricular (lv) lead, measuring greater than 2000 ohms.The sensitivity was increased and the device is now sensing and pacing appropriately.This crt-p system remains in service.No adverse patient effects were reported.

Event Description

Additional information was received which indicated that the lv lead exhibited noise.Boston scientific technical services (ts) discussed troubleshooting and reprogramming options.The crt-p and lv lead remain in service.No adverse patient effects were reported.

• Brand Name: VALITUDE X4 CRT-P
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8504308
• MDR Text Key: 141609248
• Report Number: 2124215-2019-03524
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2020
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 732498
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR