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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)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/10/2022
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system exhibited high out of range pacing impedances measuring greater than 3000 on the non-boston scientific right atrial (ra) lead. A lead safety switch (lss) was also declared which switched the pace/sense configuration from bipolar to unipolar. It was noted that impedance have intermittently increased. Additionally, there was noise observed in some atrial tachy response (atr) episodes. Technical services discussed programming options. At this time, the device and non-boston scientific ra lead remains 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 Key14023605
MDR Text Key288691613
Report Number2124215-2022-06203
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 Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/07/2022
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 Date11/02/2019
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number707461
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/05/2017
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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