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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) Back to Search Results
Model Number U128
Device Problems Over-Sensing (1438); Pacing Problem (1439); Device Sensing Problem (2917)
Patient Problem Non specific EKG/ECG Changes (1817)
Event Date 06/07/2018
Event Type  malfunction  
Event Description
It was reported that this pacemaker system exhibited noise and oversensing on both the right atrial (ra) and right ventricular (rv) leads resulting in 4 seconds of asystole. The noise was able to be reproduced with isometrics in the bipolar configuration. The physician reprogrammed the device to fixed sensitivity, and the rv sensitivity was adjusted. Additionally, the programming for several of the blanking periods was adjusted. The patient had a remote follow up the following month and there were no new episodes containing noise. The physician plans to continue to monitor. This product remains in service. No adverse patient effects were reported.
 
Event Description
This supplemental report is being filed to provide the updated conclusion code based on trend analysis.
 
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Brand NameVALITUDE X4 CRT-P
Type of DeviceCARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key8112663
MDR Text Key128744300
Report Number2124215-2018-61881
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
PMA/PMN Number
P030005/S113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/13/2018
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number708538
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2019
Is This a Reprocessed and Reused Single-Use Device? No

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