FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 2070144
·
Received April 21, 2011
Report
- Report Number
- 6000030-2011-02966
- Event Type
- Injury
- Date Received
- April 21, 2011
- Date of Event
- July 1, 2010
- Report Date
- April 7, 2011
- Manufacturer
- RICE CREEK MFG.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT HEARD AN ALARM IN (B)(6) 2010. THE PT WAS FEELING MORE PAIN AND WAS TIRED. TELEMETRY HAD CONFIRMED THAT A LOW BATTERY ALARM WAS OCCURRING. THE PUMP WAS REPLACED IN (B)(6) 2010. THE HCP STATED THAT THE CAUSE OF THE EVENT WAS A MOTOR STALL THAT DID NOT RECOVER. THE PT OUTCOME WAS REPORTED AS "DOING FINE." THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE MORPHINE SULFATE, BUPIVACAINE AND BACLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MFG. | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J11141R11 |