FDA Adverse Event
Malfunction
Summary report: N
X-STOP IPD SYSTEM
MDR report key: 1822066
·
Received August 30, 2010
Report
- Report Number
- 2953769-2010-00246
- Event Type
- Malfunction
- Date Received
- August 30, 2010
- Date of Event
- June 3, 2008
- Report Date
- July 9, 2008
- Manufacturer
- MEDTRONIC SPINE, LLC.
- Product Code
- NQO
- PMA / PMN Number
- P040001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD: DEVICE WAS NOT RETURNED; F/U WITH COMPANY REP.
Description of Event or Problem · 1
IT WAS REPORTED THAT A POST MARKET CLINICAL STUDY PT UNDERWENT AN X-STOP PROCEDURE AT LEVEL L4/L5. AN IMMEDIATE POST PROCEDURE X-RAY SHOWED THE DEVICE TO BE WELL POSITIONED. TWO-WEEK POST PROCEDURE FILMS WERE OBTAINED AND THE PHYSICIAN STATED THAT "THE DEVICE HAD MIGRATED DORSALLY". AT SIX-WEEKS POST PROCEDURE, FILMS WERE OBTAINED AND REVEALED NO CHANGE FROM THE FILMS OBTAINED AT TWO WEEKS. THE PT REMAINED ASYMPTOMATIC AND A 3 MONTH STANDARD OF CARE F/U VISIT WAS PLANNED. NO ADD'L INFO WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | X-STOP IPD SYSTEM | INTERSPINOUS PROCESS SPACER | NQO | MEDTRONIC SPINE, LLC. | NA | 2081431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |