FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 935290
·
Received October 30, 2007
Report
- Report Number
- 2182207-2007-03609
- Event Type
- Injury
- Date Received
- October 30, 2007
- Report Date
- October 3, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P790004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SEE SCANNED PAGES.
Description of Event or Problem · 1
JOURNAL REFERENCE: KESSLER, T.M., ET AL.," SACRAL NEUROMODULATION FOR REFRACTORY LOWER URINARY TRACT DYSFUNCTION: RESULTS OF A NATIONWIDE REGISTRY IN SWITZERLAND" EUROPEAN UROLOGY, (2007) 51: 1357-63. THE ARTICLE DISCUSSES THE TREATMENTS AND OUTCOMES OF PATIENTS. ADVERSE EVENTS WERE RECORDED DURING THE INITIAL TEST PHASE AND/OR DURING OR FOLLOWING TRADITIONS ONE-STAGE TECHNIQUE. DURING THE TEST PHASE, WOUND INFECTION WAS REPORTED IN TWO PATIENTS REQUIRING SURGICAL REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | EZW | MEDTRONIC NEUROMODULATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Hospitalization| R |