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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number U128
Device Problems Failure to Capture (1081); False Positive Result (1227); Pacing Problem (1439)
Patient Problems Atrial Fibrillation (1729); Chest Pain (1776); Dizziness (2194); Syncope/Fainting (4411)
Event Date 12/21/2020
Event Type  malfunction  
Manufacturer Narrative
This device has not been returned; therefore, technical analysis cannot be conducted. Investigation of the available information determined this device exhibited incorrect categorized of atrial arrhythmia(s) as mv noise. No further actions are necessary at this time.
 
Event Description
It was reported that this device was implanted and the patient underwent an atrial ventricular node ablation on the same day. The patient presented to the emergency room the next day due to lightheadedness and a potential syncopal event. Device evaluation confirmed normal device operation with good threshold measurements, capture and appropriate programming. Additionally, a boston scientific technical services consultant reviewed the stored data and all measurements were within normal limits. One month later, the patient presented to the emergency room with similar symptoms and good capture, thresholds and programming were confirmed a second time. The patient did experience episodes of atrial fibrillation and was lightheaded during these episodes. A subsequent data review was requested by this patient's physician as the patient was once again feeling lightheaded and also reported chest pain. There were no corresponding stored events that correlated with the time of the patient's symptoms. A stored pacemaker mediated tachycardia event and atrial tachycardia response events were identified. Minute ventilation had been disabled due to a signal artifact monitor episode and right atrial automatic threshold test was in suspension which was suspected to be due to the atrial fibrillation. The consultant documented the reported clinical observations and discussed programming optimization for this patient. No adverse patient effects were reported.
 
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Brand NameVALITUDE X4 CRT-P
Type of DevicePULSE 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 Key12620285
MDR Text Key276596715
Report Number2124215-2021-25177
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number756736
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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