MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9735665

Device Problems Insufficient Heating (1287); Imprecision (1307); Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670); Output Problem (3005)

Patient Problems Cognitive Changes (2551); Unspecified Tissue Injury (4559)

Event Date 01/13/2022

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 2 9631, serial/lot #: (b)(4).No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a thermal therapy system being used in a soft tissue ablation (neuro) procedure.It was reported that the target was missed and that there was no ablation possible.The target was missed by 3.3 mm despite navigation indicating a sub mm accuracy.The case was aborted.No ablation took place.The target was close to the brain stem and the ablation in the area surrounding the catheter location invalidated the possibility to ablate.The probable cause of the reported issue was that the patient reference moved from  the point of registration.The next step was to investigate why the target was missed.They think it had something to do with the patient registration.Either that the patient reference moved from point of registration or that manual registration (touch-n-go used this time) is was not accurate enough.The accuracy was too low.5 mm off at the entry and 2.5 mm at the target.They stated that future cases will be registered with o-arm.The procedure was delayed longer than an hour.The procedure was aborted.No further information was received.

Manufacturer Narrative

H2) additional information: update provided regarding patient status in section b5 and h3.H2) correction: updates made to section b5 and section d.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system and automated trajectory guidance unit being used in an electrode and probe placement procedure for a subsequent soft neuro tissue ablation with a medtronic thermal therapy system.It was reported that the target was missed and that there was no ablation possible.The target was missed by 3.3 mm despite navigation indicating a sub mm accuracy.The case was aborted.No ablation took place.The target was close to the brainstem and the ablation in the area surrounding the catheter location invalidated the possibility to ablate.The probable cause of the reported issue was that the patient reference moved from  the point of registration.The next step was to investigate why the target was missed.They think it had something to do with the patient registration.Either that the patient reference moved from point of registration or that manual registration (touch-n-go used this time) is was not accurate enough.The accuracy was too low.5 mm off at the entry and 2.5 mm at the target.They stated that future cases will be registered with o-arm.The procedure was delayed longer than an hour.The procedure was aborted.No further information was received.Additional information was received.It was clarified there was no neurological damage due to the inaccurate placement of the catheter.However, the patient was noted to be in a fragile emotional/mental state due to the reported event.

• Brand Name: STEALTHSTATION¿ S8 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13366411
• MDR Text Key: 284519211
• Report Number: 1723170-2022-00111
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Device Lot Number: N29822156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/19/2018
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 70 KG