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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN DEEP BRAIN STIMULATOR

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MEDTRONIC NEUROMODULATION UNKNOWN DEEP BRAIN STIMULATOR Back to Search Results
Model Number IPG
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/12/2010
Event Type  Injury  
Event Description

Literature: ferraye mu, debu b, fraix v, et al. Effects of pedunculopontine nucleus area stimulation on gait disorders in parkinson's disease. Brain. Jan;133(pt 1):205-214. Summary: the study looked at the effects of stimulating the pedunculopontine nucleus (ppn) area in six pts with severe freezing of gait due to parkinson's disease (pd). The pts had been unresponsive to levodopa and subthalamic nucleus (stn) stimulation. Event: one pt experienced a worsening in parkinsonism after surgically disconnecting the neurostimulator connected to the stn so a pre-operative mri could be performed. The pt suffered greatly from the arrest of the stn stimulation at the time of surgery and could no longer sustain it afterwards. At one-year f/u, stn stimulation arrest caused him severe akinesia, breathing difficulties and gait was impossible for several days afterwards, resulting in missing data. The symptoms were so severe, disconnection was not done for the remaining pts. The pt fully recovered.

 
Manufacturer Narrative

(b) (4) - used for akinesia and gait disturbance.

 
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Brand NameUNKNOWN DEEP BRAIN STIMULATOR
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
7000 central avenue
minneapolis , MN 55432-3576
7635263952
MDR Report Key1658302
Report Number3007566237-2010-02940
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 03/12/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberIPG
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/12/2010
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: 04/12/2010 Patient Sequence Number: 1
Treatment
IMPLANTED:
LEAD: MODEL 3389, LOT# UNK
EXPLANTED:
IMPLANTED:
EXPLANTED:
LEAD: MODEL 3389, LOT# UNK
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