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

Model Number U128

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Pacing Problem (1439)

Patient Problem Syncope/Fainting (4411)

Event Date 08/01/2022

Event Type  Injury  

Event Description

It was reported that this right ventricular lead exhibited high out-of-range pacing impedance measurements, which led to this cardiac resynchronization therapy pacemaker (crt-p) triggering a lead safety switch to unipolar mode.During the unipolar configuration, it was noted pacing inhibition due to myopotential noise.As a result, the patient experienced syncope.A revision procedure was performed and the rv lead was surgically abandoned.A new rv lead was placed.No additional adverse patient effects were reported.

Event Description

It was reported that this right ventricular lead exhibited high out-of-range pacing impedance measurements, which led to this cardiac resynchronization therapy pacemaker (crt-p) triggering a lead safety switch to unipolar mode.During the unipolar configuration, it was noted pacing inhibition due to myopotential noise.As a result, the patient experienced syncope.A revision procedure was performed and the rv lead was surgically abandoned.A new rv lead was placed.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, analysis of the returned device found no evidence of device defect, malfunction, or damage outside the bounds of normal medical use.The device was subjected to and passed all automated testing.Laboratory analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• 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: 15283503
• MDR Text Key: 298487969
• Report Number: 2124215-2022-31670
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2018
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 708636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/24/2022
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2016
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male