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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)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2022
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p), implanted with another manufacturer's right atrial (ra) lead, had triggered a lead safety switch (lss) due to a high out-of-range pace impedance measurement greater than 3,000 ohms. Following the lss, noise with oversensing was observed on the ra channel. Technical services (ts) recommended further lead evaluation with isometrics and pocket manipulations to determine event cause. This crt-d and ra lead remain in service. No adverse patient effects were reported.
 
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 the description 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 Key14033330
MDR Text Key288793607
Report Number2124215-2022-04773
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526559402
UDI-Public00802526559402
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 04/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/07/2018
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number711491
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/22/2016
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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