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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. STYLET KIT; STYLET, CATHETER
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MEDTRONIC, INC. STYLET KIT; STYLET, CATHETER Back to Search Results
Model Number 6057-52
Device Problem Shelf Life Exceeded (1567)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/05/2014
Event Type  malfunction  
Event Description
It was reported that at implant the stylet that was used had expired past its sterility date.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Products: (b)(4) stent graft implanted: 2010 (b)(6); (b)(4) stent graft implanted: 2010 (b)(6).(b)(4).
 
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Brand Name
STYLET KIT
Type of Device
STYLET, CATHETER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC CARDIAC RHYTHM DISEASE MGMT
8200 coral sea st ne
mounds view MN 55112
Manufacturer Contact
nashoane fulwood-kelley
8200 coral sea st ne
mounds view, MN 55112
7635260583
MDR Report Key3993018
MDR Text Key18792343
Report Number2182208-2014-02352
Device Sequence Number1
Product Code DRB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PRE-AMEND
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/27/2014
Device Model Number6057-52
Device Catalogue Number6057-52
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/05/2014
Initial Date FDA Received08/08/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
(B)(4) STENT GRAFT
Patient Age00078 YR
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