FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3203540
·
Received July 3, 2013
Report
- Report Number
- 3007566237-2013-01117
- Event Type
- Injury
- Date Received
- July 3, 2013
- Date of Event
- August 21, 2012
- Report Date
- August 21, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A PROBLEM WAS REPORTED REGARDING A PUMP. COMPANY REPRESENTATIVE REPORTED THAT AT THE BEGINNING OF THE PROCEDURE THE SURGEON OPEN THE INCORRECT DEVICE POCKET -STIM DEVICE. THE SURGEON THEN WENT AHEAD, CLOSED UP THE INCISION AND DID THE COMPLETE PROCEDURE FOR THE PUMP. A FOLLOW UP WAS REQUESTED BUT NO ADDITIONAL INFORMATION WAS RECEIVED AS OF THE TIME OF THIS REPORT. SYSTEM USED TO DELIVER MORPHINE, BUPIVACAINE AND CLONIDINE IF ADDITIONAL INFORMATION BECOMES AVAILABLE A REPORT WILL BE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306171 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 863720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00087 YR | Required Intervention |