FDA Adverse Event
Injury
Summary report: N
VENTRICULAR CATHETER, STANDARD, BIOGLIDE
MDR report key: 1841951
·
Received September 21, 2010
Report
- Report Number
- 2021898-2010-00232
- Event Type
- Injury
- Date Received
- September 21, 2010
- Date of Event
- August 26, 2010
- Report Date
- August 26, 2010
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K951258
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE HAS NOT BEEN RETURNED TO THE MFR. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. THE STERILIZATION RECORDS FOR THIS BATCH INDICATE THAT ALL PROCESSING PARAMETERS WERE WITHIN SPECS AND ALL SAMPLES PASSED QUALITY TESTING.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD HYDROCEPHALUS SYMPTOMS THAT REQUIRED THE IMPLANTATION OF A STRATA SHUNT. ALTHOUGH THE OPERATION WAS SUCCESSFUL, SEVERAL DAYS AFTER THE OPERATION, THE PT HAD A SEVERE INTRACRANIAL INFECTION THAT WAS LIFE THREATENING. THE SHUNT WAS EXPLANTED AND THE INFECTION WAS CONTROLLED. THE PT IS STABLE AND WAITING FOR A NEW IMPLANT. ON (B)(6), 2010, IT WAS REPORTED THAT THE DEVICES WERE SOAKED IN THE ANTIBIOTIC GENTAMICIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENTRICULAR CATHETER, STANDARD, BIOGLIDE | JXG | MEDTRONIC NEUROSURGERY | NA | C45569 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Life Threatening | CATALOG: 93522, LOT # C49948| ACCESSORY: CATALOG 42866, LOT # C53266| EXPLANTED:| IMPLANTED: |