FDA Adverse Event
Other
Summary report: N
SYNERGY
MDR report key: 558794
·
Received December 8, 2004
Report
- Report Number
- 6000032-2004-01653
- Event Type
- Other
- Date Received
- December 8, 2004
- Report Date
- November 29, 2004
- Manufacturer
- MEL REL, INC.
- Product Code
- LGW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
HCP REPORTED PT PRESENTED NOVEMBER 2003 WITH SIGNS OF AN INFECTION OF THE DEVICE POCKET. THESE INCLUDE REDNESS, SWELLING, AND PAIN. CULTURES OF THE DEVICE POCKET WERE OBTAINED. COAG NEGATIVE STAPH WAS THE ORGANISM CULTURED. PT DOES NOT HAVE MENINGITIS. THE PT WAS TREATED WTH IV ANTIBIOTICS AND TOTAL DEVICE SYSTEM EXPLANT. DATE UNKNOWN. DEVICE WAS NOT RETURNED TO THE MFR FOR ANALYSIS. NCP REPORTED PT'S INFECTION IS NOW RESOLVED WITHOUT DRUG WITHDRAWAL.
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 | 39 YR | Other | EXPLANT: UNK.| LEAD MODEL 3998 LOT# LB3856 IMP: 2003 EXP: UNK.| EXPLANT: UNK.| EXTENSION MODEL 7489 LOT# NHU013107V IMPLANT: 2003| EXTENSION MODEL 7489 LOT# NHU013108V IMPLANT: 2003 |