FDA Adverse Event
Malfunction
Summary report: N
EXACTA EDMS WITH PERMANENT ATTACHED STOPCOCK
MDR report key: 3771714
·
Received April 24, 2014
Report
- Report Number
- 2021898-2014-00136
- Event Type
- Malfunction
- Date Received
- April 24, 2014
- Date of Event
- March 23, 2014
- Report Date
- March 27, 2014
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K983799
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
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 LEAKED AT THE PATIENT LINE IMMEDIATELY AFTER BEING PRIMED AND CONNECTED TO THE PATIENT. THE REPORT STATES THAT THE PRODUCT WAS THEN REMOVED AND THE PATIENT WAS DRAINING CORRECTLY WITH A REPLACEMENT DEVICE. ACCORDING TO THE REPORT, THE PATIENT DID NOT INCUR ANY INJURY AS A RESULT OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249982 | EXACTA EDMS WITH PERMANENT ATTACHED STOPCOCK | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | JXG | MEDTRONIC NEUROSURGERY | 207716804 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |