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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number NEU_INS_STIMULATOR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Hemorrhage, Subdural (1894)
Event Date 08/12/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Elkouzi a, ramirez-zamora a, zeilman p, et al.Rescue levodopa-carbidopa intestinal gel (lcig) therapy in parkinson's disease patients with suboptimal response to deep brain stimulation.Ann clin transl neurol.2019.10.1002/acn3.50889 objective: to evaluate the effectiveness of levodopa-carbidopa intestinal gel (lcig) as an add-on rescue therapy following deep brain stimulation (dbs) for treatment of motor fluctuations.The researchers conducted a retrospective study using a large database of all medical and surgical pd cases at the university of florida.Six patients were identified with dbs who subsequently received rescue lcig therapy.The clinical histories, indications for intervention and outcomes were reviewed.Reported events: one patient had an asymptomatic subdural hematoma after initial left gpi lead lacement and elected not to have a contralateral lead placed for fear of further surgical complications.
 
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Brand Name
IMPLANTABLE NEUROSTIMULATOR
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key9181222
MDR Text Key170111803
Report Number3007566237-2019-02113
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P960009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation Other
Type of Report Initial
Report Date 10/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberNEU_INS_STIMULATOR
Device Catalogue NumberNEU_INS_STIMULATOR
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/01/2019
Initial Date FDA Received10/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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