FDA Adverse Event
Other
Summary report: N
INTERSTIM
MDR report key: 734905
·
Received July 13, 2006
Report
- Report Number
- 3004209178-2006-01127
- Event Type
- Other
- Date Received
- July 13, 2006
- Report Date
- June 29, 2006
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., MEDREL
- Product Code
- EZW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOTBEEN RETURNED TO MEDTRONIC INC. FOR EVALUATION. IF FURTHER INFORMATION IS RECEIVED OR THE DEVICE RETURNED, A FOLLOW-UP MEDWATCH REPORT WILL BE SENT.
Description of Event or Problem · 1
THE HCP REPORTED THAT THE PATIENT DEVELOPED REDNESS, SWELLING, DRAINANAGE AND PAIN OF THE DEVICE POCKET SITE. CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS. THE PATIENT WAS TREATED WITH BOTH ORAL AND IV ANTIBIOTICS AND THE DEVICE SYSTEM EXPLANTED. THE INFECTION IS REPORTED AS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | IPG | EZW | MDT PUERTO RICO OPERATIONS CO., MEDREL | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other | EXPLANTED: UNK| LEAD MODEL 3889, LOT # J0454935V, IMPLANTED |