FDA Adverse Event
Other
Summary report: N
INTERSTIM
MDR report key: 729022
·
Received June 22, 2006
Report
- Report Number
- 3004209178-2006-01014
- Event Type
- Other
- Date Received
- June 22, 2006
- Date of Event
- May 22, 2006
- Report Date
- June 22, 2006
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., MEDREL
- Product Code
- EZW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
TO DATE THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC INC. FOR EVALUATION.
Description of Event or Problem · 1
THE HCP REPORTED THAT THE PATIENT DEVELOPED REDNESS AND SWELLING OF THE DEVICE POCKET SITE. CULTURES OF THE DEVICE POCKET WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS. THE PATIENT WAS TREATMED WITH IV ANTIBIOTICS AND THE DEVICE SYSTEM EXPLANTED BUT NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INFECTION IS REPORTED AS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | IPG | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO., MEDREL | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Other | EXPLANTED: UNK| LEAD: MODEL 3093, LOT# V000724, IMPLANTED: 2006 |