FDA Adverse Event
Other
Summary report: N
INTERSTIM
MDR report key: 530078
·
Received June 14, 2004
Report
- Report Number
- 6000032-2004-00765
- Event Type
- Other
- Date Received
- June 14, 2004
- Date of Event
- April 9, 2004
- Report Date
- May 20, 2004
- Manufacturer
- MEL REL, INC.
- Product Code
- EZW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT DEVELOPED AN INFECTION OF THE DEVICE POCKET. CULTURES REVEALED A MULTIRESISTANT STAPHYOCOCCUS AUREUS INFECTION. THE PT WAS TREATED WITH IV ANTIBIOTICS AND THE DEVICE WAS EXPLANTED IN 2004.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | IPG | EZW | MEL REL, INC. | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other | EXT MODEL 3095 LOT# NAH013281V IMPLANT: 2004,| EXPLANTED :UNK. |