FDA Adverse Event
Malfunction
Summary report: N
KINETRA
MDR report key: 2092411
·
Received May 2, 2011
Report
- Report Number
- 9614453-2011-03191
- Event Type
- Malfunction
- Date Received
- May 2, 2011
- Date of Event
- April 14, 2011
- Report Date
- April 14, 2011
- Manufacturer
- MEDTRONIC EUROPE SARL
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS STATED THAT, DURING AN IMPLANT PROCEDURE, ONE OF THE SETSCREWS ON THE IMPLANTABLE NEUROSTIMULATOR COULD NOT BE TIGHTENED PROPERLY. ANOTHER INS WAS USED. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THE PATIENT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | MHY | MEDTRONIC EUROPE SARL | 7428 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |