Model Number 305C |
Device Problem
Appropriate Term/Code Not Available (3191)
|
Patient Problem
No Code Available (3191)
|
Event Date 07/01/2013 |
Event Type
Injury
|
Manufacturer Narrative
|
Without the return of the product, no definitive conclusion can be made regarding the clinical observation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Medtronic received information that 9 years post implant of this bioprosthetic valve, it was explanted during a heart transplant.The patient claims that the implant procedure caused or contributed to the necessitated transplant.No further adverse patient effects were reported.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|