FDA Adverse Event
Injury
Summary report: N
LYNX SYSTEM
MDR report key: 2872812
·
Received December 13, 2012
Report
- Report Number
- 3005099803-2012-06007
- Event Type
- Injury
- Date Received
- December 13, 2012
- Report Date
- November 20, 2012
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K020110
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINANT INDICATED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT, WHO IS OVER 18 YEARS OLD, WAS IMPLANTED WITH A LYNX SUPRAPUBIC SLING SYSTEM SOMETIME IN (B)(6) 2012.POST-PROCEDURE, THE PATIENT EXPERIENCES ABDOMINAL TENDERNESS, AND IT'S PAINFUL FOR HER TO BEND OVER. THE PHYSICIAN DOES NOT KNOW THE CAUSE AND SCHEDULED AN MRI TO DETERMINE THE CAUSE; HOWEVER, THE PATIENT DECLINED. IT HAS NOT YET BEEN DETERMINED WHAT THE ISSUE IS OR IF THE PATIENT WILL UNDERGO ANY SORT OF MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LYNX SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068503000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |