MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) UPGRADE PRGM 9734261 STEALTHSTATION S7; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problem Unstable (1667)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2017

Event Type  malfunction  

Manufacturer Narrative

Patient identifier field not sufficient to hold all digits, should read: (b)(6).Patient age not available from the site.Patient weight not available from the site.Device manufacturing date is unavailable.It was reported the a field representative inspected the precision aiming device (pad) and was unable to replicate the reported issue, no problems were found.No further issues reported.Product was not returned to manufacturer for analysis, therefore, no findings are possible.

Event Description

A medtronic representative reported that while in a catheter-based procedure, the surgeon was drilling and when he was in the process of removing the drill from the precision aiming device (pad), the vertek arm moved.They were able to proceed without issues.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.

Manufacturer Narrative

Product and unique device identification (udi) updated to proper value.

• Brand Name: UPGRADE PRGM 9734261 STEALTHSTATION S7
• 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: 6450415
• MDR Text Key: 71480564
• Report Number: 1723170-2017-01441
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9734261R
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2010
• 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: 69 YR
• Patient Weight: 85