FDA Adverse Event
Malfunction
Summary report: N
ALPHA OMEGA
MDR report key: 9315226
·
Received November 13, 2019
Report
- Report Number
- 9615126-2019-00002
- Event Type
- Malfunction
- Date Received
- November 13, 2019
- Date of Event
- June 18, 2019
- Report Date
- July 11, 2019
- Manufacturer
- ALPHA OMEGA ENGINEERING LTD.
- Product Code
- GZL
- UDI-DI
- 07290014954052
- PMA / PMN Number
- 172042
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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
DURING A DBS IMPLANTATION NEUROSURGERY, THE NEUROSURGEON FINISHED THE MICROELECTRODE RECODING PHASE AND PLACED THE IMPLANTED LEAD IN PLACE. THE NEUROSURGEON NOTICED THAT THE HEADSTAGE DRIVE WAS MOVING ON ITS OWN AND HAD MOVED IN 2 MM. THE NEUROSURGEON DISCONNECTED THE HEADSTAGE CABLE AND DECIDED TO CONTINUE THE NEUROSURGERY BY USING THE MANUAL ELECTRODE MOVING OPTION AND THE DBS ELECTRODE WAS SUCCESSFULLY IMPLANTED. NO ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1108148 | ALPHA OMEGA | NEURONAV | GZL | ALPHA OMEGA ENGINEERING LTD. | 07290014954052 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |