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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI STYLET KIT; STYLET, CATHETER
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MPRI STYLET KIT; STYLET, CATHETER Back to Search Results
Model Number 6094-52
Device Problem Shelf Life Exceeded (1567)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2015
Event Type  malfunction  
Manufacturer Narrative
The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).
 
Event Description
It was reported that the stylet used during implant had passed the expiration date.No patient complications have been reported as a result of this event.
 
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Brand Name
STYLET KIT
Type of Device
STYLET, CATHETER
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
Manufacturer (Section G)
MEDTRONIC CARDIAC RHYTHM HEART FAILURE
8200 coral sea st ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key5423663
MDR Text Key38295070
Report Number2649622-2016-01261
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 company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 11/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/22/2015
Device Model Number6094-52
Device Catalogue Number6094-52
Device Lot NumberV686543
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/20/2015
Date Device Manufactured03/25/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age00093 YR
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