FDA Adverse Event
Injury
Summary report: N
ITREL 3
MDR report key: 1830792
·
Received September 8, 2010
Report
- Report Number
- 6000032-2010-06881
- 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 SIX MONTHS. 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 PREVIOUS AND SUBSEQUENT DEVICES, REFER TO MANUFACTURER REPORT # 6000032-2010-06880 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 | LOT # NFE135321H| EXPLANTED:| LEAD: MODEL 3487A, LOT # L59614| IMPLANTED:| EXTENSION: MODEL 7495-25, LOT # NAF009926N| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7425| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7427| EXPLANTED:| IMPLANTED:| LOT # NAT113525H| IMPLANTED: |