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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number U228
Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/20/2019
Event Type  malfunction  
Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted. The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and associated non-boston scientific right atrial (ra) and right ventricular (rv) leads exhibited high, out-of-range pacing impedance measurements on the rv lead, with loss of capture (loc) also observed. The ra lead was oversensing ventricular activity, resulting in inappropriate atrial tachy response (atr) episodes. It was reported both leads had triggered the lead safety switch (lss) in the past. The ra lead was left in the unipolar configuration and the rv lead was reprogrammed to bipolar and the lss was programmed off. Now, however, the rv lead was intentionally reprogrammed to unipolar to obtain in-range pacing impedance measurements and normal threshold values. The sensitivity on the ra lead was decreased to mitigate oversensing the rv activity. A new remote follow-up was planned, where data was to be reviewed to ensure these programming changes were effective. The device and competitors leads remain in service. No adverse patient effects were reported.
 
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Brand NameVISIONIST 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 Key10021481
MDR Text Key189753272
Report Number2124215-2020-09856
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/19/2018
Device Model NumberU228
Device Catalogue NumberU228
Device Lot Number709710
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 Received01/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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