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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NON-INVASIVE PATIENT TRACKER; INSTRUMENT, STEREOTAXIC
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MEDTRONIC NAVIGATION, INC NON-INVASIVE PATIENT TRACKER; INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9734887
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Excessive Heating (4030)
Patient Problem Burn(s) (1757)
Event Date 04/11/2019
Event Type  Injury  
Manufacturer Narrative
Unique device identifier (udi) is unavailable.No parts have been received by the manufacturer for evaluation.Device manufacture date is unavailable.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that, while in a imri cranial resection procedure, the patient experienced a burn underneath the non-invasive patient tracker when they exited the magnetic resonance imaging (mri).There was no reported delay to the procedure due to this issue.
 
Manufacturer Narrative
The tracker has been returned for analysis.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: device manufacture date provided.(b)(4), a supplemental report will be issued.
 
Manufacturer Narrative
The tracker was returned for analysis.Functional testing found that the tracker was functioning as designed.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that, while in a imri cranial resection procedure, the patient experienced a burn underneath the non-invasive patient tracker when they exited the magnetic resonance imaging (mri).There was no reported delay to the procedure due to this issue.As part of the investigation related to ri-243515342, medtronic received additional information that the site staff indicated they used a surgical staple gun with stainless steel staples to affix the tracker to the patient¿s scalp prior to the mri scan.Due to the surgical setup of the procedure, the length of cable between the tracker and the cable bundle was approximately 11 inches (28 cm), and the cable bundle was placed on the side of the patient¿s shoulder.The patient burn was directly under the tracker approximately the size of a quarter.There was white area in the center with redness and no blistering or bleeding.There was no odor from the burn or smoke seen during the scan, although the patient had covering over their head and was isolated in the mri suite.There was no immediate pain noted as the patient was under general anesthesia.There was no damage noticed to the device.Additional complaint information was received from the manufacturer of the mr imaging system (ge healthcare) which contained the following additional details: ¿ mr system operation was normal and ready for patient scanning.¿ follow up with a mr manager at the site identified two workflow related errors that may have contributed to this event: patient was scanned with a length of cable between the tracker and the cable bundle of greater than 20 cm.The customer also noted that they did not use the ge recommended rf padding during the procedure.¿ the mr manager at the site reported that the patient was diagnosed with a 2.0 cm by 2.0 cm superficial burn on the scalp which was located directly underneath the point of contact between the patient's scalp and the medtronic tracker.The customer reported that the burn was treated with silvadene dressing.
 
Manufacturer Narrative
Correction:"unique device identifier (udi) is unavailable." inadvertently included in initial mdr submission.Value that was populated is valid.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Correction: patient age updated.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
NON-INVASIVE PATIENT TRACKER
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 Key8529722
MDR Text Key142462580
Report Number1723170-2019-01848
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141833
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2019
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Model Number9734887
Device Catalogue Number9734887
Device Lot Number190126E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2019
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age33 YR
Patient Weight78
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