FDA Adverse Event
Malfunction
Summary report: N
ITREL
MDR report key: 2061833
·
Received April 4, 2011
Report
- Report Number
- 3007566237-2011-02558
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 17, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED, THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED, THE PT'S "SPINAL DEVICE STOPPED WORKING OVER THE WEEKEND" PRIOR TO (B)(6) 2011. NO PT OR DEVICE INFORMATION COULD BE OBTAINED. FURTHER F/U IS NOT POSSIBLE AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL | NONE | LGW | MEDTRONIC NEUROMODULATION | IPG | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |