FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2193610
·
Received July 14, 2011
Report
- Report Number
- 3007566237-2011-05415
- Event Type
- Malfunction
- Date Received
- July 14, 2011
- Report Date
- June 21, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FINAL ANALYSIS REPORTED NO ANOMALIES WITH THE PUMP. THE END OF SERVICE (EOS) OCCURRED ON (B)(4) 2011 AND WAS GREATER THAN 85 MONTHS. ANALYSIS OF THE CATHETER CONCLUDED CATHETER LEAKAGE-HOLE. A HOLE WAS SEEN IN AN AREA 7.6 CM FROM THE MORE PROXIMAL PIN CONNECTOR. IT APPEARED TO BE THE RESULT OF A NEEDLE STICK.
Description of Event or Problem · 1
NO INFO WAS PROVIDED REGARDING REASON FOR EXPLANT. THE DEVICE WAS RETURNED FOR DISPOSAL ONLY.
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 | CATHETER: MODEL 8731, LOT# B007999N06| IMPLANTED:| EXPLANTED: |