MAUDE Adverse Event Report: ALPHA OMEGA ENGINEERING LTD. ALPHA OMEGA; NEURONAV

Catalog Number 700-006002-00

Device Problems Self-Activation or Keying (1557); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

The report is late due to technical issues we experienced with esg.

Event Description

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.

• Brand Name: ALPHA OMEGA
• Type of Device: NEURONAV
• Manufacturer (Section D): ALPHA OMEGA ENGINEERING LTD.; mount precipice; nazareth, 16121 02; IS 1612102
• Manufacturer (Section G): ALPHA OMEGA ENGINEERING LTD.; mount precipice; nazareth, 16121 02; IS 1612102
• Manufacturer Contact: maysana mousa ; mount precipice; nazareth, 16121-02 ; IS 1612102
• MDR Report Key: 9315226
• MDR Text Key: 206862477
• Report Number: 9615126-2019-00002
• Device Sequence Number: 1
• Product Code: GZL
• UDI-Device Identifier: 07290014954052
• UDI-Public: 07290014954052
• Combination Product (y/n): N
• PMA/PMN Number: 172042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 700-006002-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other