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Adverse Event Report

ELA MEDICAL, S.A. STELA VENTRICULAR LEAD   back to search results
Model Number BT46
Device Problems Capture, intermittent; Explanted
Event Date 12/11/1998
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

The pt underwent a surgical procedure two days after implant of his pacing system because of intermittent loss of ventricular capture.

 
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Brand NameSTELA
Type of DeviceVENTRICULAR LEAD
Baseline Brand NameSTELA
Baseline Generic NamePERMANENT PACEMAKER LEAD
Baseline Catalogue NumberBT46
Baseline Model NumberBT46
Baseline Device FamilyPERMANENT PACEMAKER LEAD
Baseline Device 510(K) NumberK904255
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed01/28/1991
Manufacturer (Section F)
ELA MEDICAL, S.A.
98 rue maurice arnoux
montrouge
FRANCE 92120
Manufacturer (Section D)
ELA MEDICAL, S.A.
98 rue maurice arnoux
montrouge
FRANCE 92120
Manufacturer Contact
2950 xenium lane n
suite 120
plymouth , MN 55441
(612) 519 -9400
Device Event Key199151
MDR Report Key205164
Event Key192599
Report Number2182863-1999-00002
Device Sequence Number1
Product CodeDTB
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/08/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date07/02/2000
Device MODEL NumberBT46
Device Catalogue NumberBT46
Device LOT NumberH980701
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/17/1999
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/08/1999
Distributor Facility Aware Date12/11/1998
Device Age5 mo
Event Location Hospital
Date Report TO Manufacturer01/08/1999
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/1998
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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