FDA Adverse Event
Other
Summary report: N
SYNERGY
MDR report key: 526122
·
Received May 20, 2004
Report
- Report Number
- 6000032-2004-00639
- Event Type
- Other
- Date Received
- May 20, 2004
- Report Date
- May 6, 2004
- Manufacturer
- MEL REL, INC.
- Product Code
- LGW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
HCP REPORTED INFECTION REQUIRING REMOVAL OF DEVICE. THE DEVICE WAS EXPLANTED AND RETURNED TO THE MFR FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | IPG | LGW | MEL REL, INC. | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other | EXP: UNK,| LEAD MODEL 3986, LOT# N26509, IMP: 2003| EXP: UNK,| LEAD MODEL 3986, LOT#N26541, IMP: 2003,| EXP: UNK,| EXT MODEL 7489, LOT# NHU012651V, IMP: 2003| EXT MODEL 7489, LOT#NHU012650V IMP: 2003| EXP: UNK. |