ITREL 3
Report
- Report Number
- 6000032-2014-00143
- Event Type
- Injury
- Date Received
- July 14, 2014
- Report Date
- June 19, 2014
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID 3487A-33, LOT# J0205007V, IMPLANTED: 2002 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: 2002 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 7427, SERIAL# (B)(4), IMPLANTED: 2002 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3487A, LOT# L69266, IMPLANTED: 1999 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: 1999 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).
(B)(4).
IT WAS REPORTED, THE PATIENT'S OTHER TWO IMPLANTS FAILED.
IT WAS FURTHER REPORTED THAT THE PROBLEMS WITH THE IMPLANT WERE BECAUSE THE WIRES BECAME DISCONNECTED FROM THE BATTERY AND THE PATIENT USED UP THE BATTERY. IT WAS UNCLEAR IF IT WAS NORMAL BATTERY DEPLETION. THE BATTERY WAS IN THE PATIENT'S RIGHT ABDOMEN AND THE PATIENT COULD FEEL A SHOCK EVERY NOW AND THEN. THE PATIENT WAS DOING WELL AND THEIR CURRENT STIMULATOR WAS WORKING AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. FOR INFORMATION REGARDING THE PATIENT'S OTHER IMPLANTABLE NEUROSTIMULATOR PLEASE REFER TO MANUFACTURER REPORT # 6000032-2014-00142.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 410428 | 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 | 00047 YR | Required Intervention |