FDA Adverse Event
Malfunction
Summary report: N
ITREL 3
MDR report key: 3172681
·
Received June 17, 2013
Report
- Report Number
- 3004209178-2013-10435
- Event Type
- Malfunction
- Date Received
- June 17, 2013
- Date of Event
- May 17, 2013
- Report Date
- May 23, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 7434A, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3986, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE LEAD; PRODUCT ID 7492, SERIAL# (B)(4), IMPLANTED: (B)(6) 1989, PRODUCT TYPE EXTENSION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PROGRAMMER GOT MOIST, SO THE PATIENT PUT IT IN THE OVEN. THE PATIENT THEN FELT A LARGE SHOCK, BUT WAS NOT INJURED. THE PATIENT HAD NOT FELT ANYTHING SINCE.
Description of Event or Problem · 1
ADDITIONAL REVIEW INDICATED THAT ALL FOUR LIGHTS WERE SHOWING SOLID ON THE PROGRAMMER. THE PROGRAMMER LIGHTS WERE ALSO NOTED TO BE FLASHING AT ONE POINT. WHEN THE BATTERIES WERE REMOVED AND REINSTALLED, THERE WERE NO LIGHTS AND NO BEEP. THE PROGRAMMER WAS FOUND TO BE CORRODED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273372 | ITREL 3 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00083 YR |