FDA Adverse Event
Injury
Summary report: N
UNKNOWN EXTERNAL NEUROSTIMULATOR
MDR report key: 3851451
·
Received June 5, 2014
Report
- Report Number
- 3007566237-2014-01538
- Event Type
- Injury
- Date Received
- June 5, 2014
- Report Date
- May 29, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS ON CIPRO FOR A URINARY TRACT INFECTION (UTI) DURING THE TRIAL. THE PATIENT ¿FELT BETTER¿ DURING THIS TIME AND DID NOT KNOW IF ¿BEING ON THE ANTIBIOTIC HELPED HER FEEL BETTER OR THE DEVICE MADE HER FEEL BETTER.¿ ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MANUFACTURING REPORT #300420917 8-2014-10177 AS THE PATIENT HAD A UTI WITH THE PERMANENT IMPLANT AS WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329084 | UNKNOWN EXTERNAL NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | NEU_ENS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |