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 False Positive Result (1227); Pacing Problem (1439); Under-Sensing (1661)

Patient Problem Atrial Fibrillation (1729)

Event Date 09/16/2021

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that review of the stored data from this device identified signal artifact monitor events which were false positives due to atrial fibrillation.Additionally, atrial undersensing resulted in pacing into the arrhythmia which was conducted into the right ventricle for more than two minutes at a rate of 235 bpm.A boston scientific technical services consultant discussed options to resolve the clinical observations.The device was subsequently explanted.No additional adverse patient effects were reported.

Event Description

It was reported that review of the stored data from this device identified signal artifact monitor events which were false positives due to atrial fibrillation.Additionally, atrial undersensing resulted in pacing into the arrhythmia which was conducted into the right ventricle for more than two minutes at a rate of 235 bpm.A boston scientific technical services consultant discussed options to resolve the clinical observations.The device was subsequently explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.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: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• 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: 13227018
• MDR Text Key: 283612666
• Report Number: 2124215-2022-00115
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2022

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: 10/15/2022
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 756941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 03/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male