FDA Adverse Event
Malfunction
Summary report: N
ITREL 3
MDR report key: 3080703
·
Received April 26, 2013
Report
- Report Number
- 6000032-2013-00106
- Event Type
- Malfunction
- Date Received
- April 26, 2013
- Report Date
- April 16, 2013
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PRODUCT ID: 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1998, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7434-E, SERIAL# (B)(4), IMPLANTED: (B)(6) 1998, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3887-28, LOT# L58413, IMPLANTED: (B)(6) 1998, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS FURTHER REPORTED THAT THE CAUSE OF THE EVENT WAS THAT THE STIMULATOR HAD REACHED THE END OF SERVICE. THE PATIENT HAD NOT DECIDED IF THEY WANTED TO REPLACE OR REMOVE THE DEVICE. THE PATIENT WAS NOT HOSPITALIZED AND THERE WERE NO INJURIES NOTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE STIMULATOR HAD NOT WORKED FOR "MORE THAN 10 YEARS." IT WAS STATED THAT THE STIMULATION WAS "TURNING OFF." ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 182566 | 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 |