FDA Adverse Event
Other
Summary report: N
POWERLINK SYSTEM
MDR report key: 795131
·
Received December 1, 2006
Report
- Report Number
- 2031527-2006-00046
- Event Type
- Other
- Date Received
- December 1, 2006
- Date of Event
- August 30, 2006
- Report Date
- December 1, 2006
- Manufacturer
- ENDOLOGIX, INC.
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
H6. 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 FOR A PATIENT IMPLANT 2 MONTHS PRIOR; PATIENT HAD RETROPERITONEAL BLEED WHICH WAS RESOLVED WITH SURGERY TO EVACUATE HEMATOMA AND REPAIR EXTERNAL ILIAC ARTERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERLINK SYSTEM | INFRARENAL BIFURCATED STENT GRAFT | MIH | ENDOLOGIX, INC. | 28-16-140BL | W06-0661 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |