Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING PROFILE 3D 36MM; RING, ANNULOPLASTY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC HEART VALVES DIVISION RING PROFILE 3D 36MM; RING, ANNULOPLASTY Back to Search Results
Model Number 680R36
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/08/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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 3 years post implant of this 36 mm annuloplasty band, the band was explanted and replace with a different model 29 mm annuloplasty band due to systolic anterior motion.No additional adverse patient effects were reported. .
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RING PROFILE 3D 36MM
Common Device Name
RING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key7264672
Report Number2025587-2018-00357
Device Sequence Number1773359
Product Code KRH
UDI-Device Identifier00613994759207
UDI-Public00613994759207
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K073324
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/12/2018
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 Date10/26/2017
Device Model Number680R36
Device Catalogue Number680R36
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/19/2018
Initial Report FDA Received Date02/12/2018
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 Age75 YR
-
-