FDA Adverse Event
Other
Summary report: N
INTERSTIM
MDR report key: 734813
·
Received July 14, 2006
Report
- Report Number
- 3004209178-2006-01133
- Event Type
- Other
- Date Received
- July 14, 2006
- Date of Event
- March 24, 2006
- Report Date
- July 14, 2006
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO MEDREL
- Product Code
- EZW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
H.6 - THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC INC. FOR EVALUATION. IF THE DEVICE IS RETURNED OR FURTHER INFO RECEIVED, A FOLLOW-UP MEDWATCH REPORT WILL BE SENT.
Description of Event or Problem · 1
THE HCP REPORED THAT THE PT DEVELOPED REDNESS AND SWELLING OF THE NEUROSTIMULATOR DEVICE POCKET. CULTURES OF THE DEVICE POCKET WERE NEGATIVE. THE PT WAS TREATED WITH ORAL 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 | 54 YR | Other | LEAD MODEL 3889, LOT # J0455220V, IMPLANTED| EXPLANTED |