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

Catalog Number	9733881
Medical Device Problem Codes	Device Stops Intermittently (1599); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.

• Brand Name: ACTIVE CRANIAL REFERENCE FRAME
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7070440
• Report Number: 1723170-2017-04875
• Device Sequence Number: 13845831
• Product Code: HAW
• UDI-Device Identifier: 00613994480637
• UDI-Public: 00613994480637
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Physician
• Device Catalogue Number: 9733881
• Device Lot Number: 140812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Initial Date Received by Manufacturer: 10/31/2017
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1