FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3201630
·
Received July 2, 2013
Report
- Report Number
- 3007566237-2013-01044
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Report Date
- February 17, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT¿S PUMP ALARMED DUE TO A LOW RESERVOIR VOLUME. THE PATIENT HAD GONE INTO ¿CRISIS.¿ IT WAS STATED THAT THE PATIENT WAS ¿ONE OF THOSE TRICKY BACLOFEN PEOPLE.¿ THE PATIENT USUALLY CAME IN FOR REFILLS A WEEK BEFORE THE ALARM DATE. IF THE PATIENT REACHES THE ALARM DATE WITHOUT A REFILL IT WAS ¿TOO LATE.¿ THE SPECIFICS OF THE PATIENT SYMPTOMS WERE NOT REPORTED. ADDITIONAL INFORMATION 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 |
|---|---|---|---|---|---|---|---|
| 303403 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00029 YR |