| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-05-01 | 0 | 1. O |
Patient 1
(B)(4). IMPLANT DATE: DEVICE WAS IMPLANTED IN (B)(6) 2015. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.
Patient 1
IT WAS REPORTED THAT THE PATIENT HAS ISSUES WITH THAT SPF UNIT. SHE STATES THAT SHE FEELS LIKE SOMETHING IS WRONG, AND THAT SHE IS EXPERIENCING PAIN IN THE AREA WHERE THE UNIT IS IMPLANTED. SHE STATES THAT HER PAIN LEVEL IS 5-7 ON A SCALE OF 1-10. SHE STATES THAT NO PART OF THE UNIT HAS BEEN EXPLANTED AND SHE CAN FEEL THE UNIT. THE PATIENT SPOKE TO HER SURGEON WHO STATED THAT SHE "SHOULDN'T BE ABLE TO FEEL IT". SHE STATED THAT SHE HAS TRIED TO HAVE AN MRI SCAN, BUT HAS BEEN TURNED DOWN BY 3 FACILITIES DUE TO MRI SAFETY INFORMATION FOUND ONLINE. THE PATIENT REFUSED THE OFFER OF THE SPF PHYSICIAN MANUAL WHICH INCLUDES MRI SAFETY INFORMATION, AND IS CURRENTLY SEARCHING FOR A NEW DOCTOR. THE UNIT STILL REMAINS IMPLANTED IN THE PATIENT AT THIS TIME. NO KNOWN ADVERSE EVENT WAS REPORTED.