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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

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BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number U128
Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)
Patient Problem Bradycardia (1751)
Event Date 01/22/2022
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker system recorded a lead safety switch (lss) due to a high out of range right ventricular (rv) pacing impedance measurement of greater than 3000 ohms. Additionally, there was some stored events due to oversensing of noise and pacing inhibition. The device was reprogrammed from polarity back to unipolar. This patient is pacemaker dependent. Boston scientific technical services consultant recommended further troubleshooting. The plan is to continue routine in-clinic follow ups and continue monitoring this patient via latitude home monitoring system. No adverse patient effects were reported. This device remains in-service.
 
Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted. The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to for more information regarding the specific circumstances of this event. Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring. A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.
 
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Brand NameVALITUDE X4 CRT-P
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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 Key13677613
MDR Text Key286638957
Report Number2124215-2022-06001
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P030005/S113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2022
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number757298
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/17/2020
Is the Device Single Use? Yes
Type of Device Usage Initial

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