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., CRMD ATLAS II PLUS DR; 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., CRMD ATLAS II PLUS DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number V-268
Device Problems High impedance (1291); Difficult to Interrogate (1331)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/12/2014
Event Type  malfunction  
Event Description
It was reported that during a device check on a routine follow up, high hv lead impedance was observed.A second impedance measurement testing was done and impedance decelerated on a lower value.Telemetry anomaly was suspected.Patient is scheduled for follow-up.
 
Manufacturer Narrative
All information provided by manufacturer, no medwatch form was received.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ATLAS II PLUS DR
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer Contact
cary lawler
645 almanor avenue
sunnyvale, CA 94085
8184932621
MDR Report Key3901017
MDR Text Key4653204
Report Number2938836-2014-12624
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
PMA/PMN Number
P910023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
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
Device Operator Health Professional
Device Expiration Date05/31/2010
Device Model NumberV-268
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/12/2014
Initial Date FDA Received06/30/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/06/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
7122/65, (B)(4)
-
-