FDA Adverse Event
Injury
Summary report: N
ITREL 3
MDR report key: 1230547
·
Received November 13, 2008
Report
- Report Number
- 3004209178-2008-07429
- Event Type
- Injury
- Date Received
- November 13, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 16, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IMPEDANCES WERE GREATER THAN 4000 OHMS. APPROXIMATELY 2 WEEKS LATER, X-RAYS WERE TAKEN. THE EXTENSION APPEARED TO BE KINKED AND WAS REPLACED. POST SURGICALLY, THE HCP WAS ABLE TO PROGRAM STIMULATION TO COVER THE PATIENT'S PAIN AREAS. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED:| IMPLANTED:| LEAD: MODEL 3487A| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489 |