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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
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/13/2010
Event Type  Injury  
Event Description

Literature: lai sc, jung sm, grattan-smith p, et al. Neuronal intranuclear inclusion disease: two cases of dopa-responsive juvenile parkinsonism with drug-induced dyskinesia. Mov disord. Jul 15 2010;25(9):1274-1279. Summary: this article described two children with neuronal intranuclear inclusion disease (niid) who presented with dopa-responsive juvenile parkinsonism, and who had initial good levodopa response that was complicated by disabling dopa-induced dyskinesia. Both patients died within 10 years of symptom onset. The article discussed differential diagnosis of clinical symptoms and neuropathological finds. Event: one female who underwent subthalamic nucleus deep brain stimulation (dbs) experienced a return of symptoms 6 months post surgery after initial improvement of tremor and bradykinesia, and depression and labile emotion one year after surgery. Subsequently, the patient experienced recurrent infections and died due to aspiration pneumonia approximately two years after surgery. The authors indicate that the patient's widespread pathology probably accounted for the lack of sustained response to dbs. The patient's motor symptoms prior to surgery had progressed rapidly and her cognitive function had declined. The patient had demonstrated severe gait ataxia, dysarthria, dysphagia, saccadic pursuit and nystagmus, blepharospasm and focal dystonia in distal limbs.

 
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. At this time no additional information was available, additional information has been requested. A copy of this article can be accessed at www. Interscience. Wiley. Com.

 
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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
diane wolf
7000 central ave ne rcw215
minneapolis , MN 55432-3568
7635263987
MDR Report Key2143015
Report Number3007566237-2011-04689
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 08/06/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/23/2011
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 Received08/06/2010
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: 06/23/2011 Patient Sequence Number: 1
Treatment
IMPLANTED:
LEAD: MODEL LEADN, LOT# UNK
EXTENSION: MODEL UNK, LOT# UNK
EXPLANTED:
IMPLANTED:
IMPLANTED:
EXPLANTED:
IMPLANTED:
EXPLANTED:
EXTENSION: MODEL UNK, LOT# UNK
EXPLANTED:
LEAD: MODEL UNK, LOT# UNK
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