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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNK DEEP BRAIN STIMULATOR

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MEDTRONIC NEUROMODULATION UNK DEEP BRAIN STIMULATOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/31/2010
Event Type  Injury  
Manufacturer Narrative

(b) (4).

 
Event Description

Literature: timmermann l, pauls ka, wieland k, et al. Dystonia in neurodegeneration with brain iron accumulation: outcome of bilateral pallidal stimulation. Brain. 2010; 133(pt 3): 701-712. Summary: this article presents multi-centre retrospective study of 16 centers to gather worldwide experiences with bilateral pallidal deep brain stimulation in pts with neurodegeneration with brain iron accumulation (nbia) and bilateral pallidal deep brain stimulation (gpi-dbs). Data was collected once preoperatively and at 2-6 and 9-15 months postoperatively. It was hypothesized that gpi-dbs in pts with nbia reduces dystonia, but was overall less effective than previously reported single cases and small series that were previously published. Reportable event: one pt experienced a dystonic storm leading to spontaneous open fracture of the left femoral bone. The initial worsening of symptoms resolved after several days of stimulation and the pt subsequently experienced marked benefit in severity of dystonia.

 
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Brand NameUNK 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
anne reali
7000 central ave ne
rcw215
minneapolis , MN 55432-3568
7635269755
MDR Report Key1661080
Report Number3007566237-2010-03079
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 04/08/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/15/2010
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 Received04/08/2010
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: 04/15/2010 Patient Sequence Number: 1
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