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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION DEEP BRAIN STIMULATION LEAD

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MEDTRONIC NEUROMODULATION DEEP BRAIN STIMULATION LEAD Back to Search Results
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury  
Manufacturer Narrative

Journal reference: slowinski, et al. "unilateral deep brain stimulation of the subthalamic nucleus for parkinson disease. " j neurosurg, 2007, 106:626-632. Due to the limitations of the data, the reportable events are being submitted by complication type. The exact relationship between each pt, the devices used and the complications experienced was not provided. It is possible that each pt may have experienced one or more than one complication. See scanned pages.

 
Event Description

Journal reference: slowinski, et al. "unilateral deep brain stimulation of the subthalamic nucleus for parkinson disease. " j neurosurg, 2007, 106:626-632. The article describes the results from a study that involved a series of 24 pts being treated with unilateral deep drain stimulation (dbs) of the subthalamic nucleus for management of advanced parkinson disease. Five pts received bilateral dbs systems during the study period. A number of pt side effects were noted during the study. Reportable events: six pts (lead n=6) experienced stimulation related side effects (confusion, difficult swallowing, double vision) that were resolved with parameter adjustments without sequela.

 
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Brand NameDEEP BRAIN STIMULATION LEAD
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave., n.e.
minneapolis MN 55421
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave., n.e.
minneapolis MN 55421
Manufacturer Contact
charlotte gasperlin
710 medtronic parkway
minneapolis , MN 55432-5604
7635050823
MDR Report Key959262
Report Number2182207-2007-04265
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Study,Literature,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 10/17/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/05/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/17/2007
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/05/2007 Patient Sequence Number: 1
Treatment
BILATERAL SYSTEMS INCLUDE: LEAD EXTENSIONS (N=2)
UNSPECIFIED-UNILATERAL SYSTEMS INCLUDE:
KINETRA 7428 (N=1) OR SOLETRA 7426 (N=2).
LEAD EXTENSIONS (N=1)
LEAD MODEL 3387 OR 3389 (N=1)
SOLETRA 7426 (N=1).
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