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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD CURRENT VR RF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC., CRMD CURRENT VR RF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number 1207-36
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Shock from Patient Lead(s) (3162)
Event Date 03/19/2015
Event Type  Injury  
Event Description
It was reported that the patient received inappropriate therapy for a bigeminal rhythm detected in the vf zone.Programming changes were made.Patient was reported to be remarkably well.
 
Manufacturer Narrative
All information provided by manufacturer, no medwatch form was received.
 
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Brand Name
CURRENT VR RF
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
sharon mathew
645 almanor avenue
sunnyvale, CA 94085
4085226327
MDR Report Key4756952
MDR Text Key18786039
Report Number2938836-2015-04474
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeGB
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
Date FDA Received05/07/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2010
Device Model Number1207-36
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/19/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/09/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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