• 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 VALITUDE 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 VALITUDE CRT-P IMPLANTABLE DEVICE Back to Search Results
Model Number U125
Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438)
Patient Problem Syncope (1610)
Event Date 10/12/2020
Event Type  Injury  
Event Description
It was reported that boston scientific technical services (ts) received a call from a health care professional (hcp) about loss of capture with nine seconds of asystole and variable impedances within normal limits on the right ventricular (rv) and left ventricular (lv) leads. The patient was in the hospital because of an ablation procedure they had done the day before. The patient experienced some presyncope. It was noted that the signal artifact monitor (sam) had disabled the device's minute ventilation (mv) sensor. Ts suspected a spring contact issue, programming options were discussed and the device was reprogrammed. It was recommended to monitor the patient for twenty-four hours post programming changes. This device was included in the recent minute ventilation sensor signal oversensing advisory population, which ts discussed with the hcp. The device and leads remain in service. No additional adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVALITUDE CRT-P
Type of DeviceIMPLANTABLE DEVICE
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 Key11103883
MDR Text Key224759508
Report Number2124215-2020-24784
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/04/2017
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number100743
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/18/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0360-2018

Patient Treatment Data
Date Received: 01/02/2021 Patient Sequence Number: 1
-
-