FDA Adverse Event
Injury
Summary report: N
ITREL 3
MDR report key: 2923812
·
Received January 22, 2013
Report
- Report Number
- 6000032-2013-00015
- Event Type
- Injury
- Date Received
- January 22, 2013
- Report Date
- December 31, 2012
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, EXPLANTED: (B)(6) 2004. PRODUCT TYPE: EXTENSION: PRODUCT ID 7434-E, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3888-28, LOT# L76086, IMPLANTED: (B)(6) 2000, EXPLANTED: (B)(6) 2004. PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A BROKEN LEAD IN 2002 AND IT WAS REVISED TWO YEARS LATER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29444 | ITREL 3 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MDT SOFAMOR DANEK PUERTO RICO MFG | 7425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |