FDA Adverse Event
Injury
Summary report: N
ITREL 3
MDR report key: 2070160
·
Received April 25, 2011
Report
- Report Number
- 3004209178-2011-03060
- Event Type
- Injury
- Date Received
- April 25, 2011
- Date of Event
- January 1, 2011
- Report Date
- April 6, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT NEEDED MRI PRIOR TO TUMOR REMOVAL; THE DEVICE WAS EXPLANTED. IT WAS ALSO NOTED THAT THE DEVICE WAS NEAR END OF LIFE. IT WAS PLANNED TO RE-IMPLANT THE PT WITH ANOTHER STIMULATOR IN THE FUTURE. THE PT OUTCOME WAS REPORTED AS "NO INJURY".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention | LEAD: MODEL 3987A, LOT# N067973| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-25, LOT# NAF017164N| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7434, LOT# YN0030075P |