FDA Adverse Event
Malfunction
Summary report: N
KINETRA
MDR report key: 2022126
·
Received February 28, 2011
Report
- Report Number
- 3007566237-2011-01491
- Event Type
- Malfunction
- Date Received
- February 28, 2011
- Date of Event
- February 1, 2011
- Report Date
- February 11, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE HEALTH CARE PROFESSIONAL REPORTED THE STIMULATOR HAD IMPEDANCE READINGS OF <250 OHMS, AND THE STIMULATOR DRAINED "FAST."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | MHY | MEDTRONIC NEUROMODULATION | 7428 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |