• 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-KISTA) FRONTIER II IMPLANTABLE PACEMAKER PULSE GENERATOR

  • 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-KISTA) FRONTIER II IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5596
Device Problem Incorrect Measurement (1383)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during a follow-up, it was noted that the pulse generator exhibited inappropriate measured longevity data. No intervention was performed. The patient was in stable condition. No additional information was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFRONTIER II
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC. (CRM-KISTA)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC. (CRM-KISTA)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
ulla strindlund
box 7051
isafjordsgatan 15
kista SE-16-407
SW   SE-16407
4684744043
MDR Report Key5691976
MDR Text Key46313696
Report Number3010215456-2016-03378
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2009
Device Model Number5596
Device Lot Number2912972
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 Received05/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/07/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-