MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL; SEE H10)

Model Number S7

Device Problems Device Stops Intermittently (1599); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information not provided due to (b)(6) patient privacy regulations.No procode, common device name and/or 510k provided as this device is not released for distribution in the united states.No parts have returned to the manufacturer for evaluation.No parts returned for analysis.

Event Description

A medtronic representative reported that while in a cranial resection procedure the positioning sensor unit (psu) sometimes did not respond/work.The system was rebooted with resolution.The procedure was completed with navigation.There was a reported delay to the procedure of 5 minutes due to this issue and no impact on the patient outcome.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.

Manufacturer Narrative

The polaris spectra system control unit (scu) was returned to the manufacturer for evaluation.After functional testing and visual/physical examination the reported issue could not be confirmed.The scu performed as expected with no issues.A check of the event logs did not reveal any adverse events.No problem was found.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used in a cranial resection.It was reported that the positioning sensor unit (psu) sometime did not respond/work.The system was rebooted with resolution.There was less than an hour in delays.No impact on patient outcome.

• Brand Name: CART 9734056 S7 STAFF SHRT 100-120V INTL
• Type of Device: SEE H10)
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7185799
• MDR Text Key: 97666239
• Report Number: 1723170-2018-00214
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10)
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S7
• Device Catalogue Number: 9734056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2012
• 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