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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 Low impedance (2285)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/05/2015
Event Type  malfunction  
Event Description
It was reported that low, out of range hv lead impedance was observed.The rv lead was replaced.When the new rv lead was connected to the chronic device, the low out of range hv lead impedance was still present.The device remains implanted and will be monitored.
 
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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 Key4760403
MDR Text Key5790212
Report Number2938836-2015-04580
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
Date FDA Received05/08/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2011
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 Manufactured03/08/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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