FDA Adverse Event
Death
Summary report: N
CARDIAC/PERITONEAL CATHETER, STANDARD, 90 CM
MDR report key: 4280867
·
Received November 26, 2014
Report
- Report Number
- 2021898-2014-00470
- Event Type
- Death
- Date Received
- November 26, 2014
- Date of Event
- October 29, 2014
- Report Date
- November 2, 2014
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K792005
- Adverse Event
- 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.
Description of Event or Problem · 1
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT WAS HOSPITALIZED FOR AN ANEURYSM. ACCORDING TO THE REPORT, THE PATIENT UNDERWENT A VENTRICULOPERITONEAL SHUNT OPERATION ON (B)(6) 2014 DUE TO INTRAVENTRICULAR HEMORRHAGE AND HYDROCEPHALUS. IT WAS REPORTED THAT AN AUTOPSY WILL NOT BE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 768120 | CARDIAC/PERITONEAL CATHETER, STANDARD, 90 CM | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | JXG | MEDTRONIC NEUROSURGERY | D57775 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00037 YR | Death |