MAUDE Adverse Event Report: ELEKTA INSTRUMENT AB LEKSELL VANTAGE STEREOTACTIC SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Lot Number	SH00039
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation found that the electrodes implanted showed a consistent caudal shift of the target.No injuries to the patient have been reported but the shift seen has resulted in displacement of the dbs (deep brain stimulation).The root cause investigation has shown that the cause was that the mri fiducial box was pushed against the inner surface of the head coil resulting in a shift of the stereotactic reference.The information and warnings in the instructions for use are sufficient for proper handling of leksell® vantagetm stereotactic system.
Event or Problem Description
The customer reported that electrodes implanted showed a consistent caudal shift of the target.

• Brand Name: LEKSELL VANTAGE STEREOTACTIC SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ELEKTA INSTRUMENT AB; kungstensgatan 18; po box 7593; stockholm, SE103 93; SW SE103 93
• MDR Report Key: 9250353
• Report Number: 9612186-2019-00008
• Device Sequence Number: 2171708
• Product Code: HAW
• UDI-Device Identifier: 07340048304375
• UDI-Public: 07340048304375
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K190887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2019

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?: No
• Operator of Device: Health Professional
• Device Lot Number: SH00039
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1