FDA Adverse Event
Malfunction
Summary report: N
IMPLANT PDS3000M 6PK PILLAR PALATAL
MDR report key: 3232820
·
Received July 18, 2013
Report
- Report Number
- 1045254-2013-00461
- Event Type
- Malfunction
- Date Received
- July 18, 2013
- Report Date
- June 25, 2013
- Manufacturer
- MEDTRONIC XOMED, INC.
- Product Code
- LRK
- PMA / PMN Number
- K040417
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. E: INITAL REPORTER IS THE PATIENT, AND MEDTRONIC HAS THIS INFORMATION ON FILE. (B)(4). EXPLANT WAS DISCARDED. THE PATIENT STATED SHE HAD THE FIRST PILLAR IMPLANT REMOVED ABOUT A WEEK AFTER THEY WERE IMPLANTED, IN LATE 2009, DUE TO PARTIAL EXTRUSION. THIS EVENT WAS FILED UNDER A SEPARATE MDR, WITH THE PATIENT IDENTIFIER AS (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT, SHE HAD A PILLAR PROCEDURE WITH 3 IMPLANTS AND AN UVULECTOMY LATE IN 2009. THE PATIENT STATED SHE HAD THREE SINUS SURGERIES IN 2010-2011 AND DURING THE LAST SURGERY; A SECOND PILLAR IMPLANT WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 334156 | IMPLANT PDS3000M 6PK PILLAR PALATAL | DEVICE, ANTI-SNORING | LRK | MEDTRONIC XOMED, INC. | PDS3000M | NOT PROVIDED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |