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

Model Number	1000689
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	01/03/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Event or Problem Description
The customer reported bleeding occuring during dbs (deep brain stimulation) surgery which led to the patient being placed in intensive care post-operatively and later died.
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.A patient from paraguay was implanted with two deep brain stimulation electrodes using a leksell stereotactic system, inomed microdrive and dbs guide tubes and boston scientific dbs leads.A bleed occurred which led to the patient being placed in intensive care postoperatively and later died.The neurosurgeon suspects that the unfortunate outcome was caused by a previous medical condition of the patient.The leksell stereotactic system has been checked regarding mechanical accuracy, both at elekta and at fredrikssons verkstäder ab as a certified verification and no faults could be found.The leksell stereotactic system was found to be working as designed and intended and was not suspected to be faulty by the user since the target was reached correctly on both sides.
Additional Manufacturer Narrative
Unfortunately, due to administrative errors, the following fields have now been updated: b1 - adverse event ticked.G4 - 510k number added.H2 - updated as correction.

• Brand Name: LEKSELL STEREOTACTIC SYSTEM - MPS ARC
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ELEKTA INSTRUMENT AB; kungstensgatan 18; po box 7593; stockholm, SE103 93; SW SE103 93
• Manufacturer (Section G): ELEKTA INSTRUMENT AB; kungstensgatan 18; po box 7593; stockholm, SE103 93; SW SE103 93
• Manufacturer Contact: pms ; kungstensgatan 18; po box 7593; stockholm, SE103- 93 ; SW SE103 93
• MDR Report Key: 16145661
• Report Number: 9612186-2023-00002
• Device Sequence Number: 5743805
• Product Code: HAW
• UDI-Device Identifier: 07340048305600
• UDI-Public: 07340048305600
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K152558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1000689
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 01/03/2023; Not provided
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 06/09/2023; 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown