FDA Adverse Event
Injury
Summary report: N
ITREL 3
MDR report key: 1983071
·
Received February 4, 2011
Report
- Report Number
- 9614453-2011-00878
- Event Type
- Injury
- Date Received
- February 4, 2011
- Date of Event
- December 1, 2010
- Report Date
- January 19, 2011
- Manufacturer
- MEDTRONIC EUROPE SARL
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ES
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE IMPLANTABLE NEUROSTIMULATOR WAS IMPLANTED (B)(6) 2009. STIMULATION PARAMETERS WERE PULSEWIDTH: 270 MICROSECONDS, RATE: 60 HERZ, AMPLITUDE: 3-3.5 VOLTS. BY (B)(6) 2010 THE HCP WAS UNABLE TO COMMUNICATE WITH THE DEVICE DUE TO END OF SERVICE. THE DEVICE WAS BELIEVED TO HAVE UNDERGONE RAPID BATTERY DEPLETION BASED UPON THE ENERGY REQUIREMENTS OF THESE PARAMETERS. IT WAS REPLACED. THERE WAS NO INJURY ASSOCIATED WITH THE EVENTS. THE PATIENT WAS OK AFTERWARD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 | LGW | MEDTRONIC EUROPE SARL | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |