FDA Adverse Event
Injury
Summary report: N
ITREL 3
MDR report key: 1872787
·
Received October 14, 2010
Report
- Report Number
- 3004209178-2010-07969
- Event Type
- Injury
- Date Received
- October 14, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 16, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION FROM HIS DEVICE. IT WAS STATED THE PATIENT BELIEVED THEIR DEVICE "WAS SITTING ON A NERVE AND NEEDED TO BE MOVED." ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
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 | 54 YR | IMPLANTED:| LEAD: MODEL 3587A, LOT# N165950| EXTENSION: MODEL 7489, LOT# NHU133486V| IMPLANTED:| PROGRAMMER: MODEL 7434A, LOT# NGL010039P| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED: |