• 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 VISIONIST 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 VISIONIST X4 CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number U228
Device Problem Pacing Problem (1439)
Patient Problem Unspecified Infection (1930)
Event Date 02/25/2022
Event Type  Injury  
Manufacturer Narrative
This product has not been returned for analysis. This report will be updated should additional information become available or if analysis is completed.
 
Event Description
It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) experienced an endless loop tachycardia below maximum tracking rate (mtr). The device was reprogrammed and the rhythm broke. In addition, the system was infected and a full extraction was planned. This device was explanted. No additional adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVISIONIST 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 CORPORATION
cashel road
clonmel
EI
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key14291397
MDR Text Key290943324
Report Number2124215-2022-14173
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526559471
UDI-Public00802526559471
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU228
Device Catalogue NumberU228
Device Lot Number769908
Was Device Available for Evaluation? No
Date Manufacturer Received03/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/10/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/05/2022 Patient Sequence Number: 1
-
-