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

Device Problems Malposition of Device (2616); No Apparent Adverse Event (3189)

Patient Problems No Known Impact Or Consequence To Patient (2692); 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

A third party supplier to a customer has reported that dbs electrodes, which have been implanted with the leksell vantage frame have shifted in a medial-posterior direction and a revision surgery is required.

• Brand Name: LEKSELL VANTAGE 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
• Manufacturer (Section G): ELEKTA INSTRUMENT AB; kungstensgatan 18; po box 7593; stockholm, SE103 93; SW SE103 93
• Manufacturer Contact: pms ; linac house; fleming way; crawley, west sussex RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 8064589
• MDR Text Key: 128400449
• Report Number: 9612186-2018-00005
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K171123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse