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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)

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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/13/2021
Event Type  Injury  
Event Description
It was reported that this patient suspected this device to be involved in a premature battery depletion field safety notice. However, it was confirmed that this device is not involved in an advisory population. Despite this, the patient requested a prophylactic explant. The device was surgically explanted and replaced to resolve the event and no additional adverse patient effects were reported. The device is expected for analysis, but has not yet been received.
 
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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 Key12659809
MDR Text Key277249775
Report Number2124215-2021-30444
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/02/2019
Device Model NumberU228
Device Catalogue NumberU228
Device Lot Number725637
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2017
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/19/2021 Patient Sequence Number: 1
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