FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1953526
·
Received January 5, 2011
Report
- Report Number
- 3007566237-2011-00082
- Event Type
- Injury
- Date Received
- January 5, 2011
- Date of Event
- December 1, 2010
- Report Date
- December 28, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PUMP AND CATHETER WERE REMOVED. THE PHYSICIAN BELIEVED THAT THE PUMP WAS LEAKING RESULTING IN CELLULITIS. ADDITIONAL INFO HAS BEEN REQUESTED A FOLLOW-UP 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 | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J11028R02 |