FDA Adverse Event
Injury
Summary report: N
IPG
MDR report key: 1082559
·
Received July 25, 2008
Report
- Report Number
- 2182207-2008-04383
- Event Type
- Injury
- Date Received
- July 25, 2008
- Report Date
- July 1, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- 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 A FOREIGN COUNTRY" EUROPEAN UROLOGY, (2007) 51: 1357-63. THE ARTICLE DISCUSSES THE TREATMENTS AND OUTCOMES OF 209 PATIENTS. ADVERSE EVENTS WERE RECORDED DURING THE INITIAL TEST PHASE AND/OR DURING OR FOLLOWING TRADITIONAL ONE-STAGE TECHNIQUE. REPORTABLE EVENT: AFTER THE IMPLANT OF THE IPG, ONE PT EXPERIENCED THE IPG MIGRATING, WHICH REQUIRED SURGERY TO REVISE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IPG | EZW | MEDTRONIC NEUROMODULATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | LEAD MODEL UNK N=1| PROGRAMMER MODEL UNK N=1 |