FDA Adverse Event
Malfunction
Summary report: N
EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER
MDR report key: 3201672
·
Received July 2, 2013
Report
- Report Number
- 2021898-2013-00221
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- June 3, 2013
- Report Date
- June 3, 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 THE PATIENT UNDERWENT SURGERY ON (B)(6) 2013. ACCORDING TO THE REPORT, THE DRAINAGE PACK WAS PLUGGING BEFORE THE SURGERY, AND THAT IT WAS STILL PLUGGING AFTER BEING PLACED IN THE PATIENT. THE REPORT STATES THAT A NEW DEVICE WAS OBTAINED AND USED TO COMPLETE THE SURGERY AND THAT THE PATIENT WAS ¿ALL OK¿ AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303247 | EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | JXG | MEDTRONIC NEUROSURGERY | 12330422 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |