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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 Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Failure to Read Input Signal (1581); Low impedance (2285)
Patient Problem Fatigue (1849)
Event Date 03/11/2021
Event Type  malfunction  
Event Description
It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) felt fatigued when performing a treadmill test. Technical services (ts) reviewed the electrogram (egm) and found there was some noise on the right atrial (ra) lead along with some pauses. However, there were no pacing inhibition of greater than two seconds. Isometrics and pocket manipulation was performed and the noise could not be reproduced. Additionally, there were stored pacemaker mediated tachycardia (pmt) episodes and some of the pauses were related to the pmt algorithm, so this was programmed off and a pause or two was related to atrial flutter. It was noted upon review of the ra lead trend there was an out of range (oor) pacing impedances measuring less than 200 ohms. This declared a lead safety switch (lss). Ts review found p-waves were high with two measuring greater than 25mv. Ts recommended to find out if the patient had any procedure that might account for the oor measurements. The field representative will discuss with the clinic. At this time, the crt-p and non-boston scientific ra lead remains in service. No 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 Key12113040
MDR Text Key260437710
Report Number2124215-2021-17858
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 07/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/08/2018
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number716029
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 Received04/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/18/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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