FDA Adverse Event
Other
Summary report: N
OSVII LOW PRO
MDR report key: 2163676
·
Received June 14, 2011
Report
- Report Number
- 9612007-2011-00024
- Event Type
- Other
- Date Received
- June 14, 2011
- Report Date
- June 14, 2011
- Manufacturer
- INTEGRA, BIOT
- Product Code
- JXG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
THE OSVII LOW PROFILE WAS IMPLANTED ON (B)(6) 2011. THE PT'S VENTRICLES DID NOT REDUCE AFTER TWO MONTHS. ON (B)(6) 2011, THE PT UNDERWENT SURGERY. THE PHYSICIAN CHECKED ALL THE CONNECTIONS ON THE OSVII LOW PROFILE AND THEY WERE INTACT. THE PHYSICIAN DECIDED TO CHANGE THE OSVII SHUNT FOR A MEDTRONIC STRATA. ADD'L CLINICAL INFO HAS BEEN REQUESTED HOWEVER, NO ADD'L INFO HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OSVII LOW PRO | OSV II LOW PRO | JXG | INTEGRA, BIOT | 159659 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |