FDA Adverse Event
Injury
Summary report: N
ITREL 3
MDR report key: 1830794
·
Received September 8, 2010
Report
- Report Number
- 6000032-2010-06880
- Event Type
- Injury
- Date Received
- September 8, 2010
- Report Date
- August 11, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO, MED REL
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT'S DEVICE LASTED ONE YEAR AND NEEDED TO BE REPLACED. THE DEVICE "STOPPED WORKING CORRECTLY." ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW-UP AS IT BECOMES AVAILABLE. FOR INFORMATION RELATED TO SUBSEQUENT DEVICES, REFER TO MANUFACTURER REPORT # 6000032-2010-06881 AND 6000032-2010-06883.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 | LGW | MDT PUERTO RICO OPERATIONS CO, MED REL | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention | EXPLANTED:| EXPLANTED:| LOT # NAT137456H| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7425| IMPLANTED:| LOT # NFE135321H| IMPLANTABLE NEURO STIMULATOR: MODEL 7427| EXTENSION: MODEL 7495-25, LOT # NAF009926N| EXPLANTED:| LEAD: MODEL 3487A, LOT # L59614| IMPLANTED: |