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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 Problems Pacing Problem (1439); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems Device Overstimulation of Tissue (1991); Presyncope (4410)
Event Date 09/03/2021
Event Type  Injury  
Event Description
It was reported that this patient experienced pre-syncopal symptoms for two days before presenting to the emergency department. Pectoral muscle twitching was also present and device interrogation revealed the device had entered safety mode. The unipolar pacing in this safety mode resulted in the pre-syncope and muscle twitching as the patient was pacemaker-dependent. The physician surgically explanted and replaced this device to resolve the event. The patient was stable with no additional adverse effects reported. The device was subsequently received for analysis.
 
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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 Key12644338
MDR Text Key276842259
Report Number2124215-2021-30447
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/07/2021
Device Model NumberU228
Device Catalogue NumberU228
Device Lot Number742358
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/17/2021 Patient Sequence Number: 1
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