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

Model Number S7

Device Problems Unstable (1667); Device Operates Differently Than Expected (2913)

Patient Problems Tissue Damage (2104); Iatrogenic Source (2498)

Event Date 07/26/2017

Event Type  Injury  

Manufacturer Narrative

Patient weight not available from the site.A medtronic representative went to site to test the equipment.Representative reported that the site confirmed that there was a video tower behind the emitter during surgery.A system checkout was performed.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.-no parts were replaced.-no parts have been received by manufacturer for evaluation.Per further engineering review of the reported event it was confirmed that the system is working as intended.The probable cause was determined to be operational technique as there was a video tower positioned behind the emitter during a case.The instructions for use (ifu) contains warnings regarding metallic objects near emitter."caution: metallic objects in or near the navigation field can degrade navigational accuracy.If metallic distortion causes excessive error, navigation will be disabled.To restore navigation, remove metallic objects from the navigation field.".

Event Description

A medtronic representative reported that during a shunt placement procedure with axiem the instrument/reference tracking was not inconsistent as the instruments were flickering on tracker details.Site informed that there was a video tower behind the emitter which reduced the tracking field due to metal in the field.The navigation was aborted and the surgery was rescheduled.There was a delay of less than 1 hour.

Manufacturer Narrative

Additional information: patient weight now provided.The exact numerical weight is (b)(6) kg.Correction: the procedure was aborted after an incision had already been made.Also, it was inadvertently reported on the initial mdr in describe event or problem that "tracking was not inconsistent as the instruments were flickering on tracker details" and should instead have stated that "tracking was inconsistent as the instruments were flickering on tracker details.".

• 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: oksana ditolla ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 6817221
• MDR Text Key: 83510263
• Report Number: 1723170-2017-03454
• Device Sequence Number: 1
• Product Code: HAW
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9734261
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2011
• 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): Required Intervention
• Patient Age: 22 YR
• Patient Weight: 43