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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P IMPLANTABLE DEVICE

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BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P IMPLANTABLE DEVICE Back to Search Results
Model Number U128
Device Problems High impedance (1291); Over-Sensing (1438); Ambient Noise Problem (2877); Impedance Problem (2950)
Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Event Date 07/03/2018
Event Type  malfunction  
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
Boston scientific received information that noise was noted on the right ventricular (rv) lead channel of this cardiac resynchronization therapy pacemaker (crt-p) due to oversensing of the minute ventilation (mv) signal. The caller inquired as to whether the device was conditionally approved for a magnetic resonance imaging (mri) scan. Boston scientific technical services (ts) advised that it was not. Non-abrupt impedance shifts were noted. Ts recommended programming mv off and evaluating right atrial (ra) lead. Ts also recommended programming to optimize if no noise was noted. No adverse patient effects were reported. Remains in service. This device was included in the recent mv sensor signal oversensing advisory population.
 
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Brand NameVALITUDE X4 CRT-P
Type of DeviceIMPLANTABLE DEVICE
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 Key7979928
MDR Text Key124174312
Report Number2124215-2018-15640
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/24/2018
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number714312
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received01/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/03/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/18/2018 Patient Sequence Number: 1
Treatment
4087; 4671; 5076; K173; U128
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