FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1162240
·
Received September 16, 2008
Report
- Report Number
- 2182207-2008-05738
- Event Type
- Malfunction
- Date Received
- September 16, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 20, 2008
- 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
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED HALLUCINATIONS. THERE WAS A VOLUME DISCREPANCY GREATER THAN 25%. THE EXPECTED RESERVOIR VOLUME WAS 17 ML, THE ACTUAL RESERVOIR VOLUME WAS 0 ML. NO PATIENT TREATMENT OR OUTCOME WAS REPORTED. ADDITIONAL 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 | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention | PROGRAMMER: MODEL 8840| EXPLANTED:| CATHETER: MODEL 8709 |