1045254-2014-00140
Report
- Report Number
- 1045254-2014-00140
- Event Type
- Injury
- Date Received
- June 25, 2014
- Report Date
- June 2, 2014
- Manufacturer
- MEDTRONIC XOMED INC.
- Product Code
- LRK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4): THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.
AGE AT TIME OF EVENT: (B)(6). DATE OF BIRTH: (B)(6) 1969. SEX: MALE. WEIGHT: (B)(6). A FOLLOW-UP WITH THE CUSTOMER INDICATES THAT THE PATIENT IS CURRENTLY ON ANTIBIOTICS AWAITING SURGICAL REMOVAL OF THEIR DEVICE (REPOSE TONGUE BASE ADVANCEMENT). THE SURGERY IS SCHEDULED FOR (B)(6) 2014. THE PATIENT BEGAN EXPERIENCING SYMPTOMS AND/OR PROBLEMS WITHIN ONE WEEK OF THEIR INITIAL SURGERY, WHICH TOOK PLACE ON (B)(6) 2007. IMPLANTED DATE: (B)(6) 2007. DATE RECEIVED BY MANUFACTURER: JULY 24, 2014.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A FOLLOW-UP WITH THE CUSTOMER INDICATES THAT THE PATIENT IS CURRENTLY ON ANTIBIOTICS AWAITING SURGICAL REMOVAL OF THEIR DEVICE (REPOSE TONGUE BASE ADVANCEMENT). THE SURGERY IS SCHEDULED FOR (B)(6) 2014. THE PATIENT BEGAN EXPERIENCING SYMPTOMS AND/OR PROBLEMS WITHIN ONE WEEK OF THEIR INITIAL SURGERY, WHICH TOOK PLACE ON (B)(6) 2007.
IT WAS REPORTED BY A PHYSICIAN THAT THEIR PATIENT HAD A REPOSE TONGUE BASE ADVANCEMENT PERFORMED BY A DIFFERENT SURGEON IN 2007. THE SUTURE BROKE AND IS STICKING UP OUT OF THE BACK OF THE TONGUE AND THE PATIENT IS NOW GETTING RECURRENT INFECTIONS. THE PHYSICIAN WOULD LIKE TO REMOVE BOTH THE SUTURE AND THE ANCHOR SCREW, IF POSSIBLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 371278 | LRK | MEDTRONIC XOMED INC. | XOM UNKNOWN ENDO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00037 YR | Other |