FDA Adverse Event
Other
Summary report: N
INTERSTIM
MDR report key: 781059
·
Received November 6, 2006
Report
- Report Number
- 3004209178-2006-01897
- Event Type
- Other
- Date Received
- November 6, 2006
- Date of Event
- November 28, 2003
- Report Date
- October 11, 2006
- Manufacturer
- MEDTRONIC 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
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
H.6: TO DATE THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC INC. FOR EVALUATION. IF FURTHER INFO IS RECEIVED OR THE DEVICE RETURNED, A FOLLOW-UP MEDWATCH REPORT WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED BY THE HCP THAT THE PATIENT DEVELOPED FEVER, SWELLING AND PAIN AT THE NEUROSTIMULATOR DEVICE POCKET SITE. CULTURES WERE TAKEN OF THE DEVICE POCKET AND WERE POSITIVE FOR SERRATIA MARCESCENS. THE PATIENT WAS TREATED WITH BOTH ORAL AND IV ANTIBIOTICS AND THE DEVICE SYSTEM EXPLANTED. THE INFECTION WAS REPORTED AS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. MEDREL | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention | EXPLANTED| EXPLANTED| LEAD MODEL 3889, LOT# J0340318V, IMPLANTED |