FDA Adverse Event
Malfunction
Summary report: N
NEURO OMEGA
MDR report key: 9315270
·
Received November 13, 2019
Report
- Report Number
- 9615126-2019-00003
- Event Type
- Malfunction
- Date Received
- November 13, 2019
- Date of Event
- October 8, 2019
- Report Date
- November 4, 2019
- Manufacturer
- ALPHA OMEGA ENGINEERING LTD.
- Product Code
- GZL
- PMA / PMN Number
- K171581
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORT IS LATE DUE TO TECHNICAL ISSUES WE EXPERIENCED WITH ESG.
Description of Event or Problem · 1
ALPHA OMEGA`S NEURO OMEGA HEADSTAGE DRIVE WAS USED DURING A ROUTINE PLACEMENT OF A DBS ELECTRODE NEUROSURGERY PROCEDURE. THE NEUROSURGEON NOTICED THAT THE HEADSTAGE DRIVE WAS MOVING ON ITS OWN AND HAD MOVED IN 2 MM. THE NEUROSURGEON DISCONNECTED THE HEADSTAGE CABLE, RESTARTED THE SYSTEM, REPLACED THE HEADSTAGE DRIVE AND CABLE AND TO CONTINUE THE NEUROSURGERY. DBS CASE WAS COMPLETED BILATERALLY SUCCESSFULLY. NO ADVERSE EVENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1108118 | NEURO OMEGA | NEURO OMEGA DRIVE HEADSTAGE | GZL | ALPHA OMEGA ENGINEERING LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |