• 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 Problems Over-Sensing (1438); Ambient Noise Problem (2877); Connection Problem (2900); Device Sensing Problem (2917)
Patient Problem Syncope (1610)
Event Date 03/07/2018
Event Type  Injury  
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete. This investigation will be updated should further information be provided.
 
Event Description
Boston scientific received information that the patient implanted with this cardiac resynchronization therapy pacemaker (crt-p) and competitor leads experienced a syncopal episode. Upon checking the device, instances of noise and oversensing were observed on both the right atrial (ra) and right ventricular (rv) leads though it was noted the recorded episode did not correspond to the time of the patient's syncope. Boston scientific technical services (ts) discussed that without further information the cause of the patient's syncope nor noise could be conclusively determined. Additional system testing was advised. The patient subsequently underwent provocation testing at which time noise was recreated with bipolar sensing programmed. An x-ray was then performed and the terminal pins of both leads could not be clearly visualized through the device header. A revision procedure was then performed wherein the leads were reinserted into the header. No additional adverse patient effects were reported. This system remains in service.
 
Manufacturer Narrative
No further information has been provided to date. This report will be updated should additional information become available.
 
Event Description
Additional information was received indicating intermittent episodes of noise and oversensing resulting in pacing inhibition continue to be observed. It was noted there have been no fluctuations in lead impedance measurements and noise is difficult to reproduce. Engineering level analysis determined the noise was likely not consistent with a device hardware issue. Ts provided suggestions for additional assessment of the leads and programming options. The device was programmed to fixed sensitivity. Despite the periods of pacing inhibition the patient remains asymptomatic. This system remains in service.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed. A visual inspection of the device header and case noted no anomalies. Pin gauge testing, designed to verify proper port dimensions, was completed. Each port measured as expected. The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested. Impedance testing was completed and all measurements were within normal limits. The device operated appropriately with no interruptions in therapy output at the returned programmed settings. A series of electrical tests was also performed, and again, normal device function was observed.
 
Event Description
New information received indicates that the device was explanted and returned for analysis.
 
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 degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key7362292
MDR Text Key103193341
Report Number2124215-2018-05043
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUK
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,Followup,Followup
Report Date 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/09/2018
Device Model NumberU228
Device Catalogue NumberU228
Device Lot Number715050
Other Device ID NumberVISIONIST X4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received10/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/23/2016
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: 03/22/2018 Patient Sequence Number: 1
Treatment
5076; U228
-
-