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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 Fracture; Device Issue; Positioning Problem
Event Date 08/01/2010
Event Type  Death  
Event Description

Literature: burdick ap, fernandez hh, okun ms, chi yy, jacobson c, foote kd. Relationship between higher rates of adverse events in deep brain stimulation using standardized prospective recording and pt outcomes. Neurosurg focus. Aug 2010;29(2):e4. Summary: the authors disclose the standardized and prospectively recorded ae data from their institution between (b)(6) 2002 and (b)(6) 2008. Two hundred seventy dbs procedures were performed in 198 pts; 26 pts had dystonia, 43 had essential tremor, 113 had parkinson disease, 6 had ocd, and 10 had other causes of tremor. The dbs leads were implanted on the left hemisphere in 133 procedures, on the right in 88, and bilaterally in 49. A total of 300 aes were recorded in 146 of the 270 procedures, and the aes were recorded in 119 of 198 pts. No significant qol differences. Event: the frequency of the 300 adverse events were as follows: mental status decline 53, other (unspecified) 43, gait problem 21, other motor problem 20, seizure 16, ich (symptomatic) 16, lead misplacement 15, speech-aphasia 13, speech-dysarthria 11, subdural/other bleed 11, mania/hypomania 8, infection, deep (hardware removal) 7, air embolus 6, speech-hypophonia 6, depression 6, infection, deep (revision, iv antibiotics) 5, swallow problem 5, anxiety 5, incontinence 4, visual problem 4, infection, superficial (oral antibiotics) 4, hardware malfunction (other) 4, death 2, hardware malfunction (fracture) 2, hydrocephalus 2, neurological deficit (other) 2, stroke 2, scalp erosion 2, suicidal ideation 2, ipg seroma 1, other sensory problem 1 and psychogenic disorder 1. See attached literature article.

 
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. The pt info provided in section a is the average for all the pts. At this time, no add'l info was available, add'l info has been requested.

 
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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
anne reali
7000 central ave. ne.
rcw215
minneapolis , MN 55432-3568
7635269755
MDR Report Key1885229
Report Number3007566237-2010-08435
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 09/22/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/25/2010
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 Received09/22/2010
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: 10/25/2010 Patient Sequence Number: 1
Treatment
UNK LEADS
UNK EXTENSIONS
UNK PROGRAMMERS
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