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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, WITH (CRT-P)

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BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P PULSE GENERATOR, WITH (CRT-P) Back to Search Results
Model Number U128
Device Problem Telemetry Discrepancy (1629)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2021
Event Type  malfunction  
Event Description
It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) was experiencing difficulty interrogating the device with their remote monitor. The patient was evaluated in the clinic and it was confirmed that the device could be interrogated with a programmer wand; however, when they attempted to confirm radio frequency (rf) telemetry the connection was lost. Device data was preserved and submitted for boston scientific engineering review. Engineering analysis showed an rf issue and recommended device replacement. This was discussed with the health care professional (hcp). No adverse patient effects were reported. The device remains in service.
 
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Brand NameVALITUDE X4 CRT-P
Type of DevicePULSE GENERATOR, WITH (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 Key12164054
MDR Text Key261448223
Report Number2124215-2021-19041
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/03/2019
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number716669
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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