FDA Adverse Event
Other
Summary report: N
INTERSTIM
MDR report key: 769759
·
Received October 5, 2006
Report
- Report Number
- 2950887-2006-01664
- Event Type
- Other
- Date Received
- October 5, 2006
- Date of Event
- September 6, 2006
- Report Date
- September 6, 2006
- Manufacturer
- MEDTRONIC GASTROENTEROLOGY/UROLOGY
- Product Code
- GZB
- PMA / PMN Number
- K013120
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS REC'D BY MEDTRONIC INC. FOR EVALUATION AND EVALUATION IS PENDING. A FOLLOW-UP MEDWATCH REPORT WILL BE SENT ONCE THE EVAL IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE MANUFACTURE'S REP THAT DURING IMPLANTATION OF AN INTERSTIM DEVICE SYSTEM, THE RADIOPAQUE RING OF THE LEAD INTRODUCER BROKE OFF IN THE PT'S FORAMEN. THE PHYSICIAN ELECTED TO LEAVE THE MARKER IN THE PT FOLLOWING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO POST-OPERATIVE PROBLEMS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | GZB | GZB | MEDTRONIC GASTROENTEROLOGY/UROLOGY | 042294 | W41743 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other |