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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) LINEAR BLUNT PROBE HC; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) LINEAR BLUNT PROBE HC; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9733879
Medical Device Problem Code Communication or Transmission Problem (2896)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/31/2017
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 manufacturer for evaluation.
 
Event or Problem Description
A medtronic representative reported that during a procedure one led on the active probe long cable was not communicating with navigation system.The procedure was completed with the use of navigation.There was no delay to procedure.No impact on patient impact.
 
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Brand Name
LINEAR BLUNT PROBE HC
Common Device Name
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
MDR Report Key6901384
Report Number1723170-2017-03940
Device Sequence Number1313279
Product Code HAW
UDI-Device Identifier00613994480613
UDI-Public00613994480613
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K050438
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date (Section B) 09/28/2017
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 Number9733879
Device Lot Number141111
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/31/2017
Initial Report FDA Received Date09/28/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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