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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NEXFRAME INSTRUMENT, STEREOTAXIC

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MEDTRONIC NEUROMODULATION NEXFRAME INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number DB-2040
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacturer representative regarding an unknown navigation system. It was reported that there was an issue during navigation using the nexframe. The caller reported they were unable to reach the intended target and were off by 1. 6mm or 1. 9mm. The caller at one point mentioned a possible 25 degree off target, or seemed to be more lateral. The issue occurred yesterday, but the caller indicated the patient was implanted and the outcome was good. Additional information was received: it was reported that the cause of the inaccuracy was not identified. It seemed the nexframe would not "reach" them when trying to align to the target. It would not allow the dot to line up in the circle. There was no confirmed shifting or other possible reasons for the inaccuracy. The type of procedure was for a lead placement. Additional troubleshooting was the surgeon attempting to align to the target several times and was 1. 7-2. 0mm off target. They removed the new probe and reattached, but they were unable to get aligned. The product was disposed and would not be returned.
 
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Brand NameNEXFRAME
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11734881
MDR Text Key250437684
Report Number2182207-2021-00708
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 04/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDB-2040
Device Catalogue NumberDB-2040
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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