FDA Adverse Event
Malfunction
Summary report: N
ITREL II
MDR report key: 1935953
·
Received December 3, 2010
Report
- Report Number
- 3004209178-2010-10199
- Event Type
- Malfunction
- Date Received
- December 3, 2010
- Report Date
- November 23, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
WHEN THE NEUROSTIMULATOR (INS) WAS TURNED OFF IT WOULD TURN ON WHEN THE PT ENTERED AN MRI FIELD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL II | MHY | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7424 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU026303V| LEAD: MODEL 3890, LOT# J0340645V| IMPLANTED:| IMPLANTED: |