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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN DEEP BRAIN STIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC NEUROMODULATION UNKNOWN DEEP BRAIN STIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number NEU_INS_STIMULATOR
Event Type  Death  
Event Description

Yun, j. Y. , jeon, b. S. , kim, h. J. , kim, y. E. , lee, j. Y. , paek, s. H. Musculoskeletal problems need more attention in deep brain stimulation for parkinson's disease. Neurology asia. 2013;18(1):53-58. Summary: this study aimed to examine factors of poor outcome by analyzing the outcomes of bilateral subthalamic deep brain stimulation in parkinson¿s disease after 3 years. We assumed that patients who could not manage independent life in their best stimulation/medication-on condition after a defined period might not have been a good surgical candidate. A poor outcome is defined as a failure to maintain functional independence at three years during a stimulation-on/medication-on state. Results: a total of (b)(4) patients underwent bilateral subthalamic deep brain stimulation and all were followed up for 3 years. We excluded one patient who had intracranial hemorrhage. (b)(4) patients of the (b)(4) patients could not keep up independent life even during their best condition for the following reasons: freezing in (b)(4) patients, dementia in (b)(4), depression in (b)(4), musculoskeletal problems in (b)(4), and cancer in (b)(4) patient. Reported events: (b)(4) patient had depression and apathy, and committed suicide. (b)(4) patient had a gait disturbance due to freezing, depression and apathy, l-spine compression fracture, and a suboptimally placed electrode dorsomedially in the right side. It was noted that the patient had back pain in the preoperative state and it was later aggravated and the l-spine compression fracture was diagnosed. (b)(4) patient had dementia and apathy, and a suboptimally placed electrode anterior ventrolaterally in the left side. (b)(4) patient had dementia and apathy, depression, and a suboptimally placed electrode dorsomedially in the right side. (b)(4) patient had a gait disturbance due to freezing, dementia and apathy, l-spine compression fracture. It was noted that the patient had back pain in the preoperative state and it was later aggravated and the l-spine compression fracture was diagnosed. (b)(4) patient had a gait disturbance due to freezing, dementia and apathy, and a suboptimally placed electrode dorsomedially in the right and left side. (b)(4) patient had a gait disturbance due to freezing, a femur fracture due to a fall, and a suboptimally placed electrode posterior dorsomedially in the left side. (b)(4) patient had a gait disturbance due to freezing, and a l-spine compression fracture. It was noted that the patient had back pain in the preoperative state and it was later aggravated and the l-spine compression fracture was diagnosed. (b)(4) patient had a gait disturbance due to freezing, a l-spine compression fracture, and a suboptimally placed electrode dorsomedially in the right side. It was noted that the patient had back pain in the preoperative state and it was later aggravated and the l-spine compression fracture was diagnosed. (b)(4) patient had a gait disturbance due to freezing; severe autonomic dysfunction with multiple system atrophy; and a suboptimally placed electrode ventrolaterally in the left sided. (b)(4) patient had a gait disturbance due to freezing and a shoulder dislocation due to a fall. (b)(4) patient had dementia and apathy, and a suboptimally placed electrode dorsomedially in the right side. Further information has been requested; a supplemental report will be submitted if additional information is received. See attached literature article.

 
Manufacturer Narrative

Date of death is an estimate only. The actual event dates were not provided. This date is based on the date of publication of the article. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. It is also possible several events occurred in one patient. The patient information provided in section a is an average for all the patients. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id neu_unknown_lead, lot# unknown, product type: lead. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id neu_unknown_lead, lot# unknown, product type: lead. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id neu_unknown_lead, lot# unknown, product type: lead. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id neu_ins_stimulator lot# unknown, product type: implantable neurostimulator. Product id neu_unknown_lead, lot# unknown, product type: lead. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id neu_unknown_lead, lot# unknown, product type: lead. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id neu_ins_stimulator, lot# unknown, product type implantable neurostimulator. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id neu_unknown_lead. Lot# unknown, product type: lead. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id neu_unknown_lead, lot# unknown, product type: lead. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id neu_unknown_lead, lot# unknown, product type: lead. Product id neu_unknown_lead, lot# unknown, product type: lead. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. (b)(4).

 
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Brand NameUNKNOWN DEEP BRAIN STIMULATOR
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 120
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55432
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis , MN 55432
7635263987
MDR Report Key3163570
Report Number3007566237-2013-01940
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 05/15/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/11/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNEU_INS_STIMULATOR
Device Catalogue NumberNEU_INS_STIMULATOR
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/15/2013
Was Device Evaluated By Manufacturer? No Answer Provided
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: 06/11/2013 Patient Sequence Number: 1
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