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U.S. Department of Health and Human Services

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

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ELEKTA INSTRUMENT AB LEKSELL STEREOTACTIC SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Device Problems Use of Device Problem (1670); Malposition of Device (2616); Activation, Positioning or SeparationProblem (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.
 
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Brand NameLEKSELL STEREOTACTIC SYSTEM
Type of DeviceNEUROLOGICAL 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 Key8343418
MDR Text Key139954500
Report Number9612186-2019-00001
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K152558
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/15/2019
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 Received01/18/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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