FDA Adverse Event
Malfunction
Summary report: N
EDM LUMBAR DRAINAGE KIT, OPEN TIP
MDR report key: 3250263
·
Received July 26, 2013
Report
- Report Number
- 2021898-2013-00254
- Event Type
- Malfunction
- Date Received
- July 26, 2013
- Date of Event
- June 16, 2013
- Report Date
- July 1, 2013
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K862303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS IMPLANTED IN THE PATIENT TO REDUCE THEIR HYDROCEPHALUS SYMPTOMS. FOUR HOURS AFTER THE IMPLANTATION SURGERY THE STOPCOCK OF KIT WAS FOUND TO BE LEAKING. THE DOCTOR REPLACED THE STOPCOCK WITH A NEW ONE. IT WAS ALSO REPORTED THAT THE PATIENT WAS IN GOOD CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 350894 | EDM LUMBAR DRAINAGE KIT, OPEN TIP | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | JXG | MEDTRONIC NEUROSURGERY | 12277427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00045 YR |