FDA Adverse Event
Injury
Summary report: N
INTEGRAL LUMBAR DRAINAGE SETS (ILDS).
MDR report key: 319631
·
Received March 12, 2001
Report
- Report Number
- 9612007-2001-00013
- Event Type
- Injury
- Date Received
- March 12, 2001
- Date of Event
- January 16, 2001
- Report Date
- February 22, 2001
- Manufacturer
- NMT NEUROSCIENCES IMPLANTS SA
- Product Code
- JXG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
BREAKAGE OF THE LUMBAR CATHETER, WHEN TRYING TO REPOSITION IT. THE PT NEEDS A 2ND SURGICAL INTERVENTION TO RETRIEVE THE CATHETER PIECE. THIS COMPLAINT HAS BEEN REPORTED TO THE MINISTRY OF HEALTH BY THE HOSP. THE INVOLVED CATHETER WAS NOT RETURNED TO NMT. NO COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10964 | INTEGRAL LUMBAR DRAINAGE SETS (ILDS). | EXTERNAL DRAINAGE SETS. | JXG | NMT NEUROSCIENCES IMPLANTS SA | NA | 106325 OR 106141 OR 106024 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |