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 CG FUTURE BAND; 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 CG FUTURE BAND; RING, ANNULOPLASTY Back to Search Results
Model Number 638BL32
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/13/2017
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 this mitral annuloplasty band was implanted and explanted during the same procedure for unknown reasons.No additional adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CG FUTURE BAND
Common Device Name
RING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key7041437
Report Number2025587-2017-02170
Device Sequence Number19115891
Product Code KRH
UDI-Device Identifier00613994758811
UDI-Public00613994758811
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K011395
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/17/2017
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 Date04/11/2022
Device Model Number638BL32
Device Catalogue Number638BL32
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/26/2017
Initial Report FDA Received Date11/17/2017
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 Age65 YR
-
-