FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1842058
·
Received September 20, 2010
Report
- Report Number
- 3007566237-2010-07113
- Event Type
- Injury
- Date Received
- September 20, 2010
- Date of Event
- August 1, 2010
- Report Date
- August 24, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT TESTED POSITIVE FOR "INFLAMMATORY CELLS" IN THE CEREBROSPINAL FLUID (CSF). THE PT'S PHYSICIAN ORDERED THE PUMP TO BE STOPPED. THE SERIOUSNESS OF ABRUPTLY STOPPING THE MEDICATION INFUSION WAS REVIEWED. THE PT'S PUMP USED LIORESAL. THERE WAS NO INFO PROVIDED REGARDING THE CONCENTRATION OR DOSAGE OF THE MEDICATION USED IN THE PT'S PUMP. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADD'L INFO WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention | EXPLANTED:| CATHETER: MODEL 8709, LOT#: J11771R03| IMPLANTED: |