FDA Adverse Event
Injury
Summary report: N
OSVII
MDR report key: 315337
·
Received February 8, 2001
Report
- Report Number
- 9612007-2001-00004
- Event Type
- Injury
- Date Received
- February 8, 2001
- Report Date
- October 17, 2000
- Manufacturer
- NMT NEUROSCIENCES IMPLANTS S.A.
- Product Code
- JXG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IN THE ATTACHED PUBLICATION: "SUBGALEAL COILING OF THE PROXIMAL AND DISTAL COMPONENTS OF A VENTRICULO-PERITONEAL SHUNTS. AN UNUSUAL COMPLICATION AND PROPOSED MECHANISM", CHILD'S NERV. SYST, 2000, 16: 493-495, ONE PT PRESENTED WITH AN ENTIRE SHUNT MIGRATED AND WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 4774 | OSVII | HYDROCEPHALUS SHUNT | JXG | NMT NEUROSCIENCES IMPLANTS S.A. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |