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

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.

• 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 Key: 7070440
• MDR Text Key: 93452413
• Report Number: 1723170-2017-04875
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994480637
• UDI-Public: 00613994480637
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• 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 Number: 9733881
• Device Lot Number: 140812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/30/2017
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1