FDA Adverse Event
Other
Summary report: N
INTERSTIM
MDR report key: 729050
·
Received June 22, 2006
Report
- Report Number
- 3004209178-2006-01013
- Event Type
- Other
- Date Received
- June 22, 2006
- Date of Event
- May 25, 2006
- Report Date
- May 26, 2006
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., MEDREL
- Product Code
- IPF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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
IT WAS REPORTED BY THE HCP THAT THE PATIENT DEVELOPMENT DRAINAGE AND POCKET EROSION AT THE SITE OF THE INCISIONAL WOUND OPENING. CULTURES OF THE DEVICE POCKET WERE POSITIVE FOR STAPH. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND THE DEVICE SYSTEM EXPLANTED BUT NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE INFECTION IS REPORTED AS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | IPG | IPF | MEDTRONIC PUERTO RICO OPERATIONS CO., MEDREL | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other | EXTENSION: MODEL 3095, LOT# NAH24878V, 5| IMPLANTED: 2005| EXPLANTED: 2006| EXPLANTED: 2006| LEAD: MODEL 3889, LOT# J0546545V, IMPLANTED: 2005 |