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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 Problem Failure to Capture (1081)
Patient Problem Dyspnea (1816)
Event Date 03/02/2021
Event Type  Injury  
Event Description
It was reported this patient experienced shortness of breath symptoms and performed a patient-initiated interrogation of their cardiac resynchronization therapy pacemaker (crt-p) system. After reviewing the remote monitoring device data transmission, the healthcare provider (hcp) contacted boston scientific technical services (ts) to review the presenting electrogram (egm) and associated left ventricular (lv) offset and pacing. Ts reviewed the presenting egm and the lv offset shows a small deflection on the lv channel prior to the right ventricular (rv) paced beat. After the rv paced beat, there is another larger deflection on the lv channel, which could be the intrinsic intraventricular delay indicating possible lv pace loss of capture. The hcp agreed and will let the clinic know about the possible lv loss of capture and provide guidance to evaluate the lv threshold and outputs during an in-office check. The device and lv lead remain 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 Key11662021
MDR Text Key245329428
Report Number2124215-2021-06215
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
Report Date 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/25/2020
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number736954
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 Received03/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/22/2018
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: 04/13/2021 Patient Sequence Number: 1
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