FDA Adverse Event
Other
Summary report: N
SYNERGY
MDR report key: 528371
·
Received June 1, 2004
Report
- Report Number
- 6000032-2004-00703
- Event Type
- Other
- Date Received
- June 1, 2004
- Date of Event
- December 9, 2003
- Report Date
- May 4, 2004
- Manufacturer
- MEL REL, INC.
- Product Code
- LGW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
HCP REPORTED PT INFECTION WAS NOT MENINGITIS. DATE OF ONSET WAS 2003. INFECTION AND SYMPTOMS WERE FEVER, REDNESS, SWELLING, DRAINAGE, PAIN, POCKET EROSION AND RIGORS. THE PRIMARY LOCATION OF THE INFECTION WAS THE DEVICE POCKET. CULTURES WERE OBTAINED FROM THE DEVICE POCKET AND THE PT'S BLOOD. TYPE OF ORGANISM IS UNK. THE PT WAS TREATED WITH BOTH IV AND ORAL ANTIBIOTICS, AND THE TOTAL DEVICE SYSTEM WAS EXPLANTED. THE INFECTION RESOLVED. THE DEVICE WAS EXPLANTED BUT NOT RETURNED TO THE MFR FOR ANALYSIS.
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 | 77 YR | Other | EXP: 2003.| LEAD: MODEL 3890, LOT# J0344011V, IMP: 2003,| EXT: MODEL 7489, LOT# NHU023442V, IMP: 2003,| EXT: MODEL 7489, LOT# NHU032579V, IMP: 2003,| EXP: 2003.| EXP: 2003.| LEAD: MODEL 3890, LOT# J0344011V, IMP: 2003,| EXP: 2003. |