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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P IMPLANTABLE DEVICE

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BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P IMPLANTABLE DEVICE Back to Search Results
Model Number U125
Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2022
Event Type  malfunction  
Event Description
It was reported that the non-boston scientific right atrial lead exhibited noise and high, out-of-range pace impedance of greater than 2000 ohms which resulted in a lead safety switch (lss). There was also a signal artifact monitor (sam) event due to minute ventilation (mv) oversensing as a result of the lss. Boston scientific technical services (ts) was contacted, and ts discussed options. The device and leads remain in service. No adverse patient effects were reported.
 
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Brand NameVALITUDE 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 Key14068655
MDR Text Key288987986
Report Number2124215-2022-09660
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526559389
UDI-Public00802526559389
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 06/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/19/2021
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number712210
Was Device Available for Evaluation? No
Date Manufacturer Received05/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/04/2019
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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