FDA Adverse Event
Other
Summary report: N
POWERLINK SYSTEM
MDR report key: 770419
·
Received October 13, 2006
Report
- Report Number
- 2031527-2006-00035
- Event Type
- Other
- Date Received
- October 13, 2006
- Date of Event
- August 18, 2006
- Report Date
- October 13, 2006
- Manufacturer
- ENDOLOGIX, INC.
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF LOT RECORDS / WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED.
Description of Event or Problem · 1
THE PHYSICIAN REPORTED ON 30-DAY FOLLOW UP FORM (DATED 10/4/06) FOR A PATIENT IMPLANT IN 2006; POST-OP GRAFT LIMB ISCHEMIA, RIGHT LOWER EXTREMITY. RESOLVED BY THROMBECTOMY AND STENTING OF RIGHT GRAFT LIMB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERLINK SYSTEM | LIMB EXTENSION STENT GRAFT | MIH | ENDOLOGIX, INC. | 16-16-88L | W05-0997 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |