FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2062009
·
Received April 6, 2011
Report
- Report Number
- 3007566237-2011-02659
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- March 28, 2011
- Report Date
- March 28, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT HAD A RETURN OF SYMPTOMS. THEY WERE SEEN IN CLINIC. THE PUMP HAD A VOLUME DISCREPANCY. THE EXPECTED RESERVOIR VOLUME WAS MUCH LESS THAN 40 MLS. THE ACTUAL VOLUME WAS 40 MLS. ADDITIONAL TROUBLESHOOTING WAS PLANNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |