MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problems No Display/Image (1183); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

Patient weight not available from the site.On 6/9/2017 a medtronic representative went to the site to perform a system checkout.The representative replaced a vga spliter 5vdc cable.After the cable was replaced system passed all testings and is performing normally.The suspected vga has not been received by manufacturer for evaluation.

Event Description

A site representative reported that during a spinal fusion procedure with a navigation system the surgeon monitor has no video and the staff monitor displays no signal.Rebooting the system did not resolve the issue.The patient was under anesthesia.The surgery, navigation and imaging were aborted prior to incision.There was delay of more than 1 hour.No impact on patient outcome.

Manufacturer Narrative

Additional information: patient weight provided.Correction: serial number provided.The hardware investigation of the returned splitter found that the reported event was related to an electrical issue.The returned +9vac power cable returned with the splitter was damaged with a wire pulled from the connector.As such it was not providing power to the splitter.The splitter itself was found to be fully functional when connected to a known good system.The reported event was confirmed.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• 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: amos jarrette ; 826 coal creek circle; attn:product quality experienc; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 6685007
• MDR Text Key: 79029252
• Report Number: 1723170-2017-02776
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450968
• UDI-Public: 00613994450968
• Combination Product (y/n): N
• PMA/PMN Number: K050438
• 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
• Report Date: 08/04/2017

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: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 07/03/2017
• Supplement Dates Manufacturer Received: 07/10/2017
• Supplement Dates FDA Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2013
• 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 Age: 48 YR
• Patient Weight: 72