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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) ACTIVE CRANIAL REFERENCE FRAME; NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) ACTIVE CRANIAL REFERENCE FRAME; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9733881
Device Problems Device Stops Intermittently (1599); Communication or Transmission Problem (2896)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/31/2017
Event Type  malfunction  
Manufacturer Narrative
Patient information not provided due to (b)(6) patient privacy regulations.No parts have been received by the manufacturer for evaluation.Part not returned for evaluation.
 
Event Description
A medtronic representative reported that during cranial resection procedure,the navigation system intermittently could not see the leds of the active head frame.The procedure was completed with the use of navigation.There was no delay to procedure.No impact on patient outcome.
 
Manufacturer Narrative
The cranial frame was returned to the manufacturer for analysis.Analysis found that when connected to a known good system, led #3 was not firing.Otherwise, the frame returned good geometry and divot error readings.Analysis found that the reported event was related to an electrical issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
ACTIVE CRANIAL REFERENCE FRAME
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
prashanth gali
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key7070440
MDR Text Key93452413
Report Number1723170-2017-04875
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994480637
UDI-Public00613994480637
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 12/13/2018
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 Physician
Device Catalogue Number9733881
Device Lot Number140812
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/31/2017
Initial Date FDA Received11/30/2017
Supplement Dates Manufacturer Received11/13/2018
Supplement Dates FDA Received12/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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