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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC S8 PREMIUM INSTRUMENT, STEREOTAXIC Back to Search Results
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.
 
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Brand NameS8 PREMIUM
Type of DeviceINSTRUMENT, 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 Key9411967
MDR Text Key169103836
Report Number1723170-2019-05857
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00763000272739
UDI-Public00763000272739
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
Number of Events Reported1
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
Date FDA Received12/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735665
Device Catalogue Number9735665
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/24/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/04/2019 Patient Sequence Number: 1
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