FDA Adverse Event
Malfunction
Summary report: N
POWER ASSIST WITH DISPLAY ASSEMBLY
MDR report key: 4713391
·
Received April 13, 2015
Report
- Report Number
- 3005677147-2015-00002
- Event Type
- Malfunction
- Date Received
- April 13, 2015
- Date of Event
- March 9, 2015
- Report Date
- April 10, 2015
- Manufacturer
- FHC, INC.
- Product Code
- HAW
- PMA / PMN Number
- K011992
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
DURING NEUROSURGERY FOR THE IMPLANTATION OF A DEEP BRAIN STIMULATION LEAD, THE NEUROLOGIST NOTICED A "CLICKING NOISE" FROM THE MICROTARGETING DRIVE MOTOR WHEN ADVANCING THE ELECTRODE PAST THE 2MM MARK. THE NEUROLOGIST AND NEUROSURGEON DECIDED TO RETRACT THE ELECTRODE BY ENGAGING THE REMOTE BUTTON THAT IS DESIGNED TO PULL THE ELECTRODE BACK UP TO THE ZERO MARK. THE ELECTRODE, HOWEVER, ADVANCED INSTEAD OF RETRACTED. THE NEUROSURGEON IMMEDIATELY REMOVED ALL DEVICES FROM THE PT. THERE WAS NO INJURY TO THE PT. THE MOTOR CONTROLLER AND REMOTE WERE DETACHED FROM THE DRIVE AND THE CASE PROCEEDED WITH MANUAL ADVANCEMENT OF THE ELECTRODE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 244083 | POWER ASSIST WITH DISPLAY ASSEMBLY | DRIVE MOTOR | HAW | FHC, INC. | 6541 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | MICROTARGETING CONTROLER| REMOTE CONTROL| MICROTARGETING DRIFE |