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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 Failure to Capture (1081); Use of Device Problem (1670); Data Problem (3196)
Patient Problem Syncope (1610)
Event Date 02/23/2020
Event Type  Injury  
Event Description
It was reported that this patient presented to the emergency room (er) following a syncopal episode. A consult review performed by boston scientific technical services (ts) indicated that the left ventricular (lv) output programming on this cardiac resynchronization therapy pacemaker (crt-p) device was below the patients threshold. Evidence is suggestive that a mistake was made in the lv output programming at the last in-office device check. Ts also noted as part of the consult review that the right ventricular automatic threshold (rvat) test from the morning the patient presented to the er indicated successful right ventricular (rv) capture below the programmed rv output. In response, the physician requested that a boston scientific representative (rep) reprogram the lv output. The patient was subsequently discharged from the hospital. The device remains in-service. No additional adverse patient effects were reported.
 
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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 Key9973360
MDR Text Key188064805
Report Number2124215-2020-08157
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
Type of Report Initial
Report Date 04/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/08/2018
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number716132
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 Received02/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/17/2020 Patient Sequence Number: 1
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