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 VALVE 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 VALVE 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 Death (1802)
Date of Event 02/04/2018
Type of Reportable Event Death
Additional Manufacturer Narrative
Product analysis: no product was returned.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 from a patient's husband that the patient died 11 days post implant of this mitral annuloplasty band.The husband reported that "the device was part of the surgery that failed".No further details were provided.It is unknown if an autopsy was performed.
 
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 VALVE DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key10442980
Report Number2025587-2020-02659
Device Sequence Number11461992
Product Code KRH
UDI-Device Identifier00613994759207
UDI-Public00613994759207
Combination Product (Y/N)N
Initial Reporter StateMN
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 Other
Type of Report Initial
Report Date (Section B) 08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Health Professional
Device Expiration Date05/31/2022
Device Model Number680R36
Device Catalogue Number680R36
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/28/2020
Initial Report FDA Received Date08/24/2020
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 Death;
Patient Age72 YR
-
-