Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GALLANT VR; No Match
  • 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
 

ABBOTT GALLANT VR; No Match Back to Search Results
Model Number CDVRA500Q
Device Problem Failure to Convert Rhythm (1540)
Patient Problem Arrhythmia (1721)
Event Date 06/29/2023
Event Type  Injury  
Event Description
It was reported that the patient required three shocks to terminate their ventricular fibrillation episode.Reprogramming was recommended to resolve the event.The patient was stable and will continue to be monitored.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GALLANT VR
Type of Device
No Match
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key17374867
MDR Text Key319535013
Report Number2017865-2023-36458
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067031990
UDI-Public05415067031990
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCDVRA500Q
Device Catalogue NumberCDVRA500Q
Device Lot NumberP000164076
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/30/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
-
-