FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 2220252
·
Received August 16, 2011
Report
- Report Number
- 6000030-2011-06407
- Event Type
- Injury
- Date Received
- August 16, 2011
- Report Date
- August 1, 2011
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): FINAL ANALYSIS OF THE DEVICE REVEALED NO SIGNIFICANT ANOMALIES, BATTERY DEPLETION END OF LIFE.
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED THAT THE "PUMP WAS REMOVED SHORTLY AFTER IMPLANT BECAUSE IT WAS FLIPPED". IT WAS LATER REPORTED THAT THE PUMP WAS REMOVED DUE TO "BATTERY DEPLETION". THE DRUGS DELIVERED INCLUDED MORPHINE AND BUPIVACAINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | LKK | RICE CREEK MFG | 8617L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention | EXPLANTED:| CATHETER: MODEL 8709, LOT# L55029| IMPLANTED: |