MAUDE Adverse Event Report: INTEGRA BURLINGTON, MA, INC. NEUROSIGHT ARC ON LAPTOP; N/A

Catalog Number ST1000

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2020

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A surgeon reported false coordinates in the neurosight arc on laptop (product id st1000) during a deep brain stimulation (dbs) procedure.There was no surgery delay and the procedure went on as scheduled as they were not aware of the glitch.The issue was discovered within two (2) hours after the procedure while reviewing a postoperative ct scan.They reconstructed the steps taken while using the software for surgical planning to discover how the glitch came about and changed the use of the software to avoid the sequence of steps causing the glitch for all future cases.Patient suffered no adverse medical effects from the implant placed in the wrong location, and revision surgery was performed without incident the following morning to correct the location of the implant.

Event Description

N/a.

Manufacturer Narrative

The neuro sight arc was not returned for evaluation (as per sales representative, product not available) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: NEUROSIGHT ARC ON LAPTOP
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA BURLINGTON, MA, INC.; 22 terry avenue; 22 terry avenue; burlington MA 01803
• MDR Report Key: 10953966
• MDR Text Key: 219865574
• Report Number: 1222895-2020-00001
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K010548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ST1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1