FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 2250614
·
Received September 9, 2011
Report
- Report Number
- 3007566237-2011-07674
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- January 1, 2011
- Report Date
- September 1, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT HAD THEIR CATHETER REVISED BECAUSE OF A CEREBROSPINAL FLUID (CSF) LEAK. THE CATHETER HAD BEEN USED FOR INTRATHECAL BACLOFEN THERAPY (LIORESAL). ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | UNK | LKK | MEDTRONIC NEUROMODULATION | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8781, LOT UNK |