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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD
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ST. JUDE MEDICAL, INC., CRMD DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD Back to Search Results
Model Number 7120Q/65
Device Problem No Device Output (1435)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/04/2014
Event Type  malfunction  
Event Description
It was reported that during implant, is was not possible to obtain electrical measurements with the lead.Lead was not implanted.
 
Manufacturer Narrative
All information provided by manufacturer, no medwatch form was received.Analysis was normal.No anomaly was found.
 
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Brand Name
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
Type of Device
DEFIBRILLATION LEAD
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 Key4070309
MDR Text Key15108999
Report Number2938836-2014-15622
Device Sequence Number1
Product Code NVY
Combination Product (y/n)N
PMA/PMN Number
P950022
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 Received09/08/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2017
Device Model Number7120Q/65
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/04/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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