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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

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BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER Back to Search Results
Model Number U128
Device Problem High impedance (1291)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2021
Event Type  malfunction  
Manufacturer Narrative
This investigation will be updated should further pertinent information be provided.
 
Event Description
It was reported that this system with a cardiac resynchronization therapy pacemaker (crt-p) and a non bsc right ventricular (rv) lead has been showing high, out of range pacing impedances over the last year. No noise was reproducible in the configuration it is. The crt-p and the rv lead remain in service at this time. According to the field representative, no corrective actions have been completed at this time. Patient will follow up with electrophysiologist as scheduled. No adverse patient effects were reported.
 
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Brand NameVALITUDE X4 CRT-P
Type of DeviceCARDIAC RESYNCHRONIZATION THERAPY PACEMAKER
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 Key14107371
MDR Text Key289263014
Report Number2124215-2022-10582
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 04/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number717462
Was Device Available for Evaluation? No
Date Manufacturer Received02/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/21/2017
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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