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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 IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/01/2009
Event Type  Death  
Event Description

Literature: van nuenen bk, esselink ra, munneke m, speelman jd, va laar t, bloem br. Postoperative gait deterioration after bilateral subthalamic nucleus stimulation in parkinson's disease. Mov disord. 2008; 23(16): 2404-2406. Summary: the aim of this study was to evaluate the effects of subthalamic nucleus (stn) stimulation on gait relative to global outcome in a group of consecutively operated pts who had received stn stimulation between 2001 and 2004 in two major neurosurgical centers. All pts had the clinical diagnosis of parkinson's disease. A questionaire was sent to a total consecutive pts. A delayed worsening of gait after bilateral stn stimulation was experienced by a considerable proportion of pts (42% of subjects, for gait in the off phase), and this was apparently relatively selective because their global outcome scores continued to be improved. These findings highlight the presence of a hitherto poorly recognized long-term complication of bilateral stn stimulation. Event: one pt died. The cause was unk at the time of this report and f/u has been initiated.

 
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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 ave
minneapolis , MN 55432-3576
7635263952
MDR Report Key1422461
Report Number2182207-2009-05174
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 02/06/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberIPGNEURO
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/06/2009
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: 07/27/2009 Patient Sequence Number: 1
Treatment
LEAD: MODEL UNK
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