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Adverse Event Report

ELA MEDICAL, S.A. STELA ATRIAL LEAD   back to search results
Model Number BJ45
Device Problems Explanted; Premature explantation
Event Date 04/16/1999
Event Type  Injury   Patient Outcome  Hospitalization; Required Intervention
Event Description

After 8 days of implantation, the lead was explanted because of a pocket infection.

 
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Brand NameSTELA
Type of DeviceATRIAL LEAD
Baseline Brand NameSTELA
Baseline Generic NamePERMANENT PACEMAKER LEAD
Baseline Catalogue NumberBJ45
Baseline Model NumberBJ45
Baseline Device FamilyPERMANENT PACEMAKER LEAD
Baseline Device 510(K) NumberK963738
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed05/23/1997
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 (Section G)
ELA MEDICAL, INC.
14401 w. 65th way
arvada CO 80004 3599
Manufacturer Contact
christina doty
2950 xenium lane n.
suite 120
plymouth , MN 55441
(763) 519 -9400
Device Event Key219183
MDR Report Key226021
Event Key212137
Report Number2182863-1999-00023
Device Sequence Number1
Product CodeDTB
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/04/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/04/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date06/04/1999
Device MODEL NumberBJ45
Device Catalogue NumberBJ45
Device LOT Number970602
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/03/1999
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/04/1999
Distributor Facility Aware Date04/22/1999
Device Age17 mo
Event Location Hospital
Date Report TO Manufacturer06/04/1999
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/1997
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device? Yes
Type of Device Usage Initial

Database last updated on January 30, 2009

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