FDA Adverse Event
Other
Summary report: N
INTERSTIM
MDR report key: 753693
·
Received August 17, 2006
Report
- Report Number
- 3004209178-2006-01372
- Event Type
- Other
- Date Received
- August 17, 2006
- Date of Event
- November 1, 2005
- Report Date
- August 17, 2006
- Manufacturer
- MED REL, JUNCOS
- Product Code
- EZW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO MEDTRONIC INC FOR EVALUATION.
Description of Event or Problem · 1
THE HCP REPORTED THAT THE PT DEVELOPED PAIN AND DRAINAGE AT THE NEUROSTIMULATOR DEVICE POCKET SITE. CULTURES WERE TAKEN AND WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS. THE PT WAS TREATED WITH ORAL ANTIBIOTICS AND THE DEVICE SYSTEM WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | IPG | EZW | MED REL, JUNCOS | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other | IMPLANTED| EXPLANTED| LEAD MODEL 3093 LOT#J0546486V |