• 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 CRT-P; IMPLANTABLE DEVICE

  • 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 CRT-P; IMPLANTABLE DEVICE Back to Search Results
Model Number U226
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 04/09/2019
Event Type  malfunction  
Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.
 
Event Description
It was reported that this device recorded a code 1003 during pre-implant interrogation due to an unknown reason.The device was interrogated again, but the alert was unable to be cleared.No patient involvement.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, it was noted that the device was returned in the original sterile packaging.An evaluation of the device was performed.Review of the device memory confirmed that a low voltage alert, code 1003, was recorded and that the device recorded low temperature readings prior to setting the low voltage alert.If this model device is stored in environments where temperatures can drop below the recommended storage temperature, battery voltage readings that are low enough to set a low voltage alert may result.This appears to be the case with this device.The battery did recover after the device was removed from the cold.
 
Event Description
This supplemental report is being filed to include the product investigation details.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VISIONIST CRT-P
Type of Device
IMPLANTABLE DEVICE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key8722880
MDR Text Key148793035
Report Number2124215-2019-10474
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526559457
UDI-Public00802526559457
Combination Product (y/n)N
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/23/2020
Device Model NumberU226
Device Catalogue NumberU226
Device Lot Number700791
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2019
Date Manufacturer Received07/17/2019
Patient Sequence Number1
-
-