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: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ASSURA MP (DDQP+); IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
  • 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
 

ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ASSURA MP (DDQP+); IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3269-40Q
Medical Device Problem Code Over-Sensing (1438)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/18/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event or Problem Description
It was reported that when the asymptomatic patient presented for follow-up in clinic, post-paced t-wave oversensing was observed on ventricular channel on a stored electrogram (egm).Programming changes were made.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
QUADRA ASSURA MP (DDQP+)
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
MDR Report Key8867426
Report Number2938836-2019-06758
Device Sequence Number2390413
Product Code LWS
UDI-Device Identifier05414734505710
UDI-Public05414734505710
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P910023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 08/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date10/31/2014
Device Model NumberCD3269-40Q
Device Lot Number4066248
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/26/2019
Initial Report FDA Received Date08/06/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-