FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1180913
·
Received September 23, 2008
Report
- Report Number
- 2182207-2008-06041
- Event Type
- Malfunction
- Date Received
- September 23, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 28, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PUMP HAD MORE VOLUME THAN EXPECTED. THE EXPECTED RESERVOIR VOLUME WAS 0 MLS; THE ACTUAL WAS 35 MLS. THE PUMP WAS CONFIRMED TO BE FLIPPED VIA AN X-RAY OR CT SCAN (DATE NOT REPORTED). NO PT SYMPTOMS WERE REPORTED. THE MEDICATION BEING DELIVERED VIA THE PUMP WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HEALTH CARE PROFESSIONAL, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | CATHETER: MODEL 8709SC| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8840 |