MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problems Communication or Transmission Problem (2896); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2015

Event Type  malfunction  

Event Description

A medtronic representative reported that, while in a cranial procedure, was unable to merge patient exams in framelink.The medtronic representative attempted several times and used pointmerge unsuccessfully.Using coronal and sagittal planes to merge did not resolve the issue.The merge was with a magnetic resonance imaging (mr) taken on-site, to a computed tomography (ct) taken with a non-medtronic portable computed tomography imaging device.Synergy cranial was used to merge, however, results remained the same.The surgeon opted to halt the procedure and re-schedule.There was no incision made and no harm to the patient.

Manufacturer Narrative

Patient identifier and weight were not made available from the site.On (b)(4) 2015, a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.On (b)(4) 2015, a medtronic representative, following-up at the site, reported the re-scheduled surgery was performed on (b)(6) 2015 with new computed tomography (ct) and t1 scans.Surgeon did a 4 point pointmerge to merge the two scans and was satisfied with the outcome.Surgery was completed on (b)(6) 2015.On (b)(6) 2015 software investigation finds the problem was caused because the patient was intubated, which does not follow tbs-170.After re-scanning the patient without intubation the case was successful.Software is functioning as designed.On (b)(6) 2015, medtronic technical services specialist received patient scans, were able to successfully merge t1 and ct exams using a 3 point reference before the automerge.All exams included neck anatomy making the merge without picking the reference points off.Recommendation made regarding proper scan protocol: the exams should not include the neck and to include tip of the nose, soft pallet, back and top of the head.(b)(4).

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer Contact: judi ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 4600632
• MDR Text Key: 5628500
• Report Number: 1723170-2015-00318
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/12/2015

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 Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2011
• 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
• Patient Age: 64 YR