• Decrease font size
  • Return font size to normal
  • Increase font size
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)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 High impedance (1291); Device Sensing Problem (2917)
Patient Problem Atrial Fibrillation (1729)
Event Date 09/15/2018
Event Type  malfunction  
Manufacturer Narrative
Attempts were made to gather additional information regarding this event, but none was available. This investigation will be updated should further information be provided.
 
Event Description
It was reported that an automatic safety switch from bipolar to unipolar occurred due to a pacing impedance measurement of greater than 2000 ohms on this patient's non boston scientific left ventricular lead. There was also noise noted, although it was not impacting sensing. The patient reportedly had chronic atrial fibrillation. Boston scientific technical services provided explanation and advice to the health care provider. The cardiac resynchronization therapy defibrillator remains in service, as does the non boston scientific left ventricular lead. No adverse patient effects were noted.
 
Manufacturer Narrative
Attempts were made to gather additional information regarding this event, but none was available. This investigation will be updated should further information be provided.
 
Event Description
This supplemental report is being filed because the evaluation codes have been updated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 CLONMEL LIMITED
cashel road
clonmel
EI
Manufacturer Contact
timothy degroot
4100 hamline avenue north
,
saint paul, MN 55112
6515826168
MDR Report Key8016395
MDR Text Key125383495
Report Number2124215-2018-60754
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
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 12/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/19/2019
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number728254
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 Received11/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-