FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1890229
·
Received October 22, 2010
Report
- Report Number
- 3007566237-2010-08321
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- August 3, 2010
- Report Date
- August 3, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE PUMP HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A POSSIBLE PUMP MALFUNCTION. THE RESIDUAL AMOUNT IN THE PUMP WAS 12CC. THE PT WAS COMPLAINING ABOUT NEW NECK PAIN, ALTHOUGH THE HEALTH CARE PROFESSIONAL INDICATED THAT THE PAIN STEMMED FROM HER MOTOR VEHICLE ACCIDENT IN (B)(6) 2010. IT WAS UNCLEAR WHETHER THERE WAS A LOSS OF DRUG EFFECT. THE PUMP WAS REPLACED. THE PT FULLY RECOVERED. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYS WAS FENTANYL. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U 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 | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | CATHETER: MODEL 8709, LOT# J53381R10| EXPLANTED:| IMPLANTED: |