FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 920885
·
Received September 21, 2007
Report
- Report Number
- 3004209178-2007-03063
- Event Type
- Injury
- Date Received
- September 21, 2007
- Report Date
- January 18, 2005
- Manufacturer
- MPROC, JUNCO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED WHICH COVERS A 2-YEAR RETROSPECTIVE REVIEW OF EVENTS REPORTED BY CONSUMERS BETWEEN JANUARY 1, 2005 AND DECEMBER 31, 2006 (INCLUSIVE). THIS EXEMPTION WAS GRANTED TO SATISFY MEDTRONIC'S MDR OBLIGATIONS FOR ANY PREVIOUSLY UNREPORTED SERIOUS INJURY, DEATH AND MALFUNCTION EVENTS FOUND DURING THIS REVIEW. THIS MEDWATCH REPORT REPRESENTS 44 UNREPORTED SERIOUS INJURY EVENTS FOR MODEL 3023 FOR THE ABOVE TIME PERIOD (PRODUCT CODE EZW).
Description of Event or Problem · 1
THE PATIENT REPORTED TINGLING IN THE TOES. IT WAS THOUGHT THE LEAD HAD MOVED. A REVISION WAS SCHEDULED THE FOLLOWING DAY. THE HCP WAS GOING TO MOVE THE ENTIRE SYSTEM TO THE OPPOSITE SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MPROC, JUNCO | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |