FDA Adverse Event Injury Summary report: N

BRAVO

MDR report key: 920888 · Received September 21, 2007

Report

Report Number: 2032545-2007-03061
Event Type: Injury
Date Received: September 21, 2007
Report Date: February 21, 2005
Manufacturer: ARIZONA DEVICE MANUFACTURING
Product Code: FFT
PMA / PMN Number: K002028
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT IS BEING FILED WHICH COVERS A 2-YEAR RETROSPECTIVE REVIEW OF EVENTS REPORTED BY CONSUMERS BETWEEN JANUARY 1, 2005 AND DECEMBER 31, 2006 (INCLUSIVE). THIS EXEMPTION WAS GRANTED TO SATISFY MEDTRONIC'S MDR OBLIGATIONS FOR ANY PREVIOUSLY UNREPORTED SERIOUS INJURY, DEATH AND MALFUNCTION EVENTS FOUND DURING THIS REVIEW. THIS MEDWATCH REPORT REPRESENTS 3 SERIOUS INJURY EVENTS FOR MODEL 9012B1001 FOR THE ABOVE TIME PERIOD (PRODUCT CODE FFT). SEE THE ATTACHED SUMMARY REPORT FOR A LISTING OF THE EVENT.)

Description of Event or Problem · 1

THE PATIENT STATED THEY HAD CONSTANT PAIN, ESPECIALLY WHEN SWALLOWING, SINCE THE BRAVO WAS PLACED. THE PATIENT SOUGHT MEDICAL ATTENTION. AN ATTEMPT TO DISLODGE THE BRAVO FAILED. THE PATIENT EXPRESSED CONCERN THERE WAS TISSUE EROSION AND/OR THE TISSUE WOULD TEAR WITH FURTHER ATTEMPTS TO REMOVE IT ENDOSCOPICALLY. THE PATIENT WILL CONTINUE TO WORK WITH THE HCP.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	BRAVO		FFT	ARIZONA DEVICE MANUFACTURING	9012B1001	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	YR		Required Intervention