FDA Adverse Event
Other
Summary report: N
INTERSTIM
MDR report key: 601617
·
Received May 10, 2005
Report
- Report Number
- 6000032-2005-00728
- Event Type
- Other
- Date Received
- May 10, 2005
- Date of Event
- March 10, 2005
- Report Date
- April 21, 2005
- Manufacturer
- MEL REL, INC.
- Product Code
- EZW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT DEVELOPED QUESTIONABLE CELLULITIS PRIOR TO THE 2ND STAGE PROCEDURE. IT APPEARED THAT THE CELLULITIS HAD RESOLVED. HOWEVER, APPROXIMATELY 10 DAYS AFTER THE 2ND STAGE PROCEDURE, THE PATIENT DEVELOPED REDNESS AND DRAINAGE AT THE INCISIONAL WOUND SITE. CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS EPIDERMITIS. THE PATIENT WAS TREATED WITH IV AND ORAL ANTIBIOTICS AND THE DEVICE SYSTEM WAS EXPLANTED. THE INFECTION IS REPORTED TO HAVE RESOLVED.
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 | 26 YR | Other |