FDA Adverse Event
Injury
Summary report: N
ITREL 3
MDR report key: 1910976
·
Received November 23, 2010
Report
- Report Number
- 6000032-2010-09897
- Event Type
- Injury
- Date Received
- November 23, 2010
- Date of Event
- October 22, 2010
- Report Date
- November 16, 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
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS ORIGINALLY REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. ON SATURDAY, HE STARTED TO HAVE PAIN ABOVE HIS RIGHT EYE AND THE RIGHT EYE STARTED TO CLOSE. THE HEALTH CARE PROFESSIONAL CONFIRMED THE PATIENT EXPERIENCED OCCIPITAL NEURALGIA ON THE RIGHT. HE WAS UNABLE TO FULLY OPEN HIS EYE ON THE RIGHT SIDE AND EXPERIENCED RESTRICTED NECK RANGE OF MOTION. THERE WERE SUSPECTED DEVICE MALFUNCTIONS. HE HAD SURGERY ON (B)(6) 2010 AND WAS SEEN POST-OP ON (B)(6) 2010. HE WAS DOING WELL AND MEDICALLY STABLE.
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 | 58 YR | Required Intervention | EXPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0078252N| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3887, LOT# L78768| PROGRAMMER: MODEL 7434A, LOT# NGL016911P |