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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 Problems Electrical Lead; Extender; Generator; Fracture; High impedance; Migration or Expulsion of Device ; Device Operates Differently Than Expected; Device-Device Incompatibility; Unintended Movement
Event Date 10/01/2009
Event Type  Injury  
Event Description

Literature: morishita t, foote kd, burdick ap, et al. Identification and management of deep brain stimulation intra- and postoperative urgencies and emergencies. Parkinsonism relat disord. 2010; 16(3):153-162. Summary: this article reviewed, identified, and suggested management strategies for both intra- and postoperative urgencies and emergencies in deep brain stimulation (dbs) pts, and separated the scenarios into surgery/procedure related; hardware related; stimulation-induced difficulties; and others. Ten case studies were included for illustrative purposes. Complications with dbs-specific manifestations were selected and a search was performed on each issue. The case examples were taken from a database between (b)(6) 2002 to (b)(6) 2009. An unspecified number of pts with parkinson's disease or dystonia experienced a returned of non-motor symptoms upon battery "failure," including depression and suicidal ideation. An unspecified number of pts with parkinson's disease and dystonia experienced a return of motor symptoms with battery "failure," including tremor, gait problems, and stiff legs. The source literature did not specify which device models were used. The pt info provided in section a is the average for all pts. At this time, no add'l info was available, add'l info regarding the pt, event, interventions and outcome has been requested.

 
Manufacturer Narrative

(b)(4). This report is being submitted late due to a delay by a manufacturer employee. A process improvement plan and training are in place.

 
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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 avenue ne
rcw215
minneapolis , MN 55432-3568
7635263987
MDR Report Key2103904
Report Number3007566237-2011-03721
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 04/20/2010
1 Device Was Involved in the Event
11 PatientS WERE Involved in the Event:1 2 3 4 5 6 7 8 9 10 11 
Date FDA Received05/20/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
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 Received04/20/2010
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: 05/20/2011 Patient Sequence Number: 1
Treatment
IMPLANTED:
LEAD: MODEL UNK, LOT# UNK
EXTENSION: MODEL UNK, LOT# UNK
EXPLANTED:
IMPLANTED:
EXPLANTED:
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