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. UNIFY ASSURA ICD; 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. UNIFY ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3361-40C
Device Problem Failure to Interrogate (1332)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2017
Event Type  malfunction  
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 Description
It was reported that the device could not be interrogated during a follow-up.No intervention was performed and the patient will be monitored via follow-ups.The patient was stable.Further information was requested but was not available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNIFY ASSURA ICD
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
645 almanor avenue
sunnyvale CA 94085
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
645 almanor avenue
sunnyvale CA 94085
Manufacturer Contact
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7147502
MDR Text Key95837454
Report Number2938836-2017-35418
Device Sequence Number1
Product Code NIK
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 company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 12/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2016
Device Model NumberCD3361-40C
Device Lot Number4708682
Other Device ID Number05414734508223
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/22/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-