MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S8 PREMIUM; INSTRUMENT, STEREOTAXIC

Model Number 9735665

Device Problems Material Integrity Problem (2978); Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

Patient weight not available from the site.No parts have been received by the manufacturer for evaluation because it was discarded at the site.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 sacroiliac and thoracolumbar procedure.It was reported that after the case, the health care professional (hcp) discovered that a perc pin was left in the patient.It was discovered shortly after the case and removed with no negative impact to the patient.The site is not currently alleging any deficiency or complaint against medtronic or medtronic products.There was no delay to the case.No impact on patient outcome.Additional information received stating that there had been a miscommunication on this reported issue.The perc pin was not left in the patient, however the 150 mm perc pin cannula was left in the patient.According to the manufacturer representative (rep) the health care professional (hcp) did not use the slap hammer to remove the per pin.They instead grabbed the reference frame with the pin attached and removed it all together.The tissue protector/cannula was left in the patient.The hcp communicated this to the rep during a conversation they had 2 days after the issue had occurred.The site was not currently alleging any deficiencies or complaints against medtronic.The patient was brought back into surgery 24 hours later to remove the cannula when the hcp noticed it on the post-operative xrays.

Manufacturer Narrative

Patient gender and patient weight received.Additional information was received and added to the event description.Please refer to medwatch report# 2200710000-2019-8074.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received stating that in this case, the navigation procedure was not accurate/reliable, so it was aborted.This led to the removal of the reference frame with the spheres as well as the antenna from the iliac crest site, which again is a stab incision.That site was then closed with a suture and staple.The next day, the intra¿operative films were again reviewed and noticed that there appeared to be a metallic object in the area of the left iliac crest.Under monitored anesthesia care, the retained metallic object was removed by reopening the small incision over the left posterior superior iliac spine.

• Brand Name: S8 PREMIUM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9411967
• MDR Text Key: 169103836
• Report Number: 1723170-2019-05857
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00763000272739
• UDI-Public: 00763000272739
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

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: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2019
• 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: 61 YR
• Patient Weight: 110