FDA Adverse Event
Injury
Summary report: N
BIOGLIDE® PERITONEAL CATHETER 8 SLITS
MDR report key: 3250395
·
Received July 26, 2013
Report
- Report Number
- 2021898-2013-00255
- Event Type
- Injury
- Date Received
- July 26, 2013
- Date of Event
- June 24, 2013
- Report Date
- June 27, 2013
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K951258
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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 A PERITONEAL CATHETER WAS REVISED BECAUSE IT HAD "RUPTURED." THE CATHETER WAS REPORTED TO HAVE BEEN IMPLANTED SEVERAL YEARS AGO. IT WAS ALSO REPORTED THAT THE PATIENT DID NOT "SHOW ANY SIGNS OF HEALTH HAZARD" RELATED TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349594 | BIOGLIDE® PERITONEAL CATHETER 8 SLITS | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | JXG | MEDTRONIC NEUROSURGERY | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |