FDA Adverse Event
Injury
Summary report: N
X-STOP IPD SYSTEM
MDR report key: 1902457
·
Received October 22, 2010
Report
- Report Number
- 2953769-2010-00563
- Event Type
- Injury
- Date Received
- October 22, 2010
- Date of Event
- December 1, 2009
- Report Date
- September 23, 2010
- Manufacturer
- MEDTRONIC SPINE LLC
- Product Code
- NQO
- PMA / PMN Number
- P040001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD - DEVICE WAS NOT RETURNED; FOLLOWED UP WITH COMPANY REPRESENTATIVE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A (B)(6), PATIENT UNDERWENT AN X-STOP PROCEDURE. APPROXIMATELY FOURTEEN MONTHS POST PROCEDURE, THE PATIENT NOTED INCREASED LEFT LATERAL THIGH PAIN. REPORTEDLY, THERE WAS NO SPECIFIC CAUSE OR INJURY FOR THESE SYMPTOMS. NO ADDITIONAL INFORMATION 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |