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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION RING ANNULOPLSTY TRICUSP CONTOUR 3D 34MM; RING, ANNULOPLASTY
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MEDTRONIC HEART VALVE DIVISION RING ANNULOPLSTY TRICUSP CONTOUR 3D 34MM; RING, ANNULOPLASTY Back to Search Results
Model Number 690R34
Medical Device Problem Code Off-Label Use (1494)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/24/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received information that this annuloplasty ring was implanted after the expiration date.No adverse patient effects were reported.
 
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Brand Name
RING ANNULOPLSTY TRICUSP CONTOUR 3D 34MM
Common Device Name
RING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC HEART VALVE DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key7801233
Report Number2025587-2018-02195
Device Sequence Number11354102
Product Code KRH
UDI-Device Identifier00643169121713
UDI-Public00643169121713
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K101212
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date05/12/2018
Device Model Number690R34
Device Catalogue Number690R34
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/25/2018
Initial Report FDA Received Date08/21/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age44 YR
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