FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1884897
·
Received October 20, 2010
Report
- Report Number
- 3007566237-2010-08146
- Event Type
- Malfunction
- Date Received
- October 20, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 22, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A VOLUME DISCREPANCY WITH THE PUMP. THE ACTUAL RESIDUAL VOLUME WAS 19.8 ML AND THE EXPECTED RESIDUAL VOLUME WAS 4.2 ML. THE SYMPTOMS REPORTED WERE INCREASED BASELINE PAIN. THERE WERE NO ALARMS AND NO DIAGNOSTIC STUDIES HAD BEEN PERFORMED. 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 II | LKK | MEDTRONIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | IMPLANTED:| CATHETER: MODEL 8709, LOT# N004905913| EXPLANTED: |