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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 DEFIBRILLATION LEAD

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ST. JUDE MEDICAL, INC., CRMD DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD Back to Search Results
Model Number 7120/65
Event Date 07/28/2013
Event Type  Death  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient suffered from a vf attack, the patient received therapy. The vf persisted and subsequent shocks were aborted due a low hv lead impedance. Cpr was initiated and the patient was resuscitated. The patient remained in the icu in critical condition and on ventilator support. It was later reported that the patient expired. No further information is available.

 
Manufacturer Narrative

No medwatch form was received.

 
Manufacturer Narrative

A partial lead with the connector pin measuring 7. 3cm was returned for analysis. The portion of the lead that was returned was normal. Without return of the entire lead, a complete analysis could not be performed.

 
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Brand NameDURATA STS OPTIM ACTIVE FIXATION
Type of DeviceDEFIBRILLATION 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
cary lawler
645 almanor avenue
sunnyvale , CA 94085
8184932621
MDR Report Key3314521
Report Number2938836-2013-05009
Device Sequence Number1
Product CodeLWS
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/28/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date07/31/2011
Device MODEL Number7120/65
Device Catalogue NumberSMTFY999
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/20/2013
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date07/28/2013
Device Age61 mo
Event Location Hospital
Date Manufacturer Received07/29/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/09/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/28/2013 Patient Sequence Number: 1
Treatment
V-168, 482106
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