FDA Adverse Event
Injury
Summary report: N
LYNX SYSTEM
MDR report key: 2970356
·
Received February 20, 2013
Report
- Report Number
- 3005099803-2013-00937
- Event Type
- Injury
- Date Received
- February 20, 2013
- Report Date
- February 1, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K020110
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH A LYNX SUPRAPUBIC MID-URETHRAL SLING SYSTEM DURING A PROCEDURE ON (B)(6), 2009. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS (SPECIFICS UNKNOWN).ACCORDING TO THE PHYSICIAN, THERE WERE NO COMPLICATIONS DURING OR FOLLOWING THE PROCEDURE. THE PATIENT HAS NOT BEEN SEEN SINCE 2008.ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 73406 | LYNX SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | UNK564 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |