FDA Adverse Event
Other
Summary report: N
POWERLINK SYSTEM
MDR report key: 756511
·
Received August 29, 2006
Report
- Report Number
- 2031527-2006-00025
- Event Type
- Other
- Date Received
- August 29, 2006
- Date of Event
- August 18, 2006
- Report Date
- August 29, 2006
- Manufacturer
- ENDOLOGIX, INC.
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, 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 A 30-DAY FOLLOW UP FORM FOR A PATIENT IMPLANT IN 2006, THAT IN A FOLLOW UP VISIT ON 8/01/06, THE PATIENT HAD A TYPE I ENDOLEAK. THE PATIENT WAS TREATED WITH A PROXIMAL CUFF ON 8/18/06 AND THE ENDOLEAK WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERLINK SYSTEM | INFRARENAL BIFURCATED STENT GRAFT | MIH | ENDOLOGIX, INC. | 28-16-155BL | W06-0131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |