SOLOTRAK KR 6209BTK NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-02-10 for SOLOTRAK KR 6209BTK NA manufactured by Medtronic Inc., Cardiac Rhythm Management Division.

MAUDE Entry Details

Report Number2182208-2002-00202
MDR Report Key831626
Report Source05
Date Received2005-02-10
Date of Event2002-02-05
Date Facility Aware2002-02-05
Date Mfgr Received2002-02-05
Device Manufacturer Date2001-06-01
Date Added to Maude2007-03-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNI
Event Type3
Type of Report3

Device Details

Brand NameSOLOTRAK KR
Generic NamePERMANENT LEAD INTRODUCER
Product CodeDTF
Date Received2005-02-10
Model Number6209BTK
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Age11 MO
Device Eval'ed by MfgrR
Implant FlagY
Date RemovedA
Device Sequence No1
Device Event Key818967
ManufacturerMEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT DIVISION
Manufacturer AddressRICE CREEK CENTER 7000 CENTRAL AVE., NE / T279 MINNEAPOLIS MN 554323576 US
Baseline Brand NameSOLO TRAK KR
Baseline Generic NamePERMANENT LEAD INTRODUCER
Baseline Model No6209BTK
Baseline Catalog NoNA
Baseline IDNA
Baseline Device FamilyPERMANENT LEAD INTRODUCER
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]24
Baseline PMA FlagY
Premarket ApprovalK9513
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2005-02-10

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