FDA Adverse Event
Other
Summary report: N
INTERSTIM
MDR report key: 774412
·
Received October 24, 2006
Report
- Report Number
- 3004209178-2006-01795
- Event Type
- Other
- Date Received
- October 24, 2006
- Date of Event
- October 2, 2006
- Report Date
- October 5, 2006
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., MEDREL
- Product Code
- EZW
- PMA / PMN Number
- P970004
- 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 DEVCIE HAS NOT BEEN 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 AND DRAINAGE OF THE INTERSTIM NEUROSTIMULATOR DEVICE POCKET. THE PATIENT DID NOT HAVE MENINGITIS. CULTURES OF THE DEVICE POCKET WERE POSITIVE FOR MULTIRESISTANT STAPHYLOCOCCUS AUREUS. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS AND THE DEVICE SYSTEM REMOVED. THE INFECTION IS REPORTED AS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | EZW | MDT PUERTO RICO OPERATIONS CO., MEDREL | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | EXPLANTED| LEAD MODEL 3889, LOT# V008430, IMPLANTED |