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

Device Problems Use of Device Problem (1670); Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

Event Description

The customer reported that the dbs lead did not implant correctly.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the reported information.The root cause has not been identified, but the information received indicates that the root cause is probably incorrect setting of the x co-ordinate for the second electrode.The x co-ordinate used during the treatment was not according to the planned treatment protocol.No reports from the customer or the distributor indicate that an equipment failure was involved in the event.There are instructions and warnings included in the lss instruction for use to ensure setting the co-ordinates correctly.Based on this information there is no indication of device malfunction.Due to the age of the equipment, it is recommended to replace the system with the latest design of the multipurpose arc, which includes a counter scale.

Event Description

The customer reported that the dbs lead did not implant correctly.

• Brand Name: LEKSELL STEREOTACTIC SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ELEKTA INSTRUMENT AB; kungstensgatan 18; po box 7593; stockholm, SE103 93; SW SE103 93
• MDR Report Key: 8343418
• MDR Text Key: 139954500
• Report Number: 9612186-2019-00001
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K152558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1