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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION RING PROFILE 3D 36MM; RING, ANNULOPLASTY
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MEDTRONIC HEART VALVE DIVISION RING PROFILE 3D 36MM; RING, ANNULOPLASTY Back to Search Results
Model Number 680R36
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Non specific EKG/ECG Changes (1817)
Date of Event 08/31/2018
Type of Reportable Event Serious Injury
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 four days post implant of this annuloplasty ring, a permanent pacemaker was implanted due to sinus node dysfunction and unspecified atrial arrhythmia.No additional adverse patient effects were reported. .
 
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Brand Name
RING PROFILE 3D 36MM
Common Device Name
RING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC HEART VALVE DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key7957456
Report Number2025587-2018-02719
Device Sequence Number930290
Product Code KRH
UDI-Device Identifier00613994759207
UDI-Public00613994759207
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K073324
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/11/2018
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 Date05/21/2023
Device Model Number680R36
Device Catalogue Number680R36
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/20/2018
Initial Report FDA Received Date10/11/2018
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 Age77 YR
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