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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number NEU_INS_STIMULATOR
Event Date 09/09/2013
Event Type  Injury  
Event Description

Chopra, a. , abulseoud, o. A. , sampson, s. , lee, k. H. , klassen, b. T. , fields, j. A. , matsumoto, j. Y. , adams, a. C. , stoppel, c. J. , geske, j. R. , frye, m. A. Mood stability in parkinson disease following deep brain stimulation: a 6-month prospective follow-up study. Psychosomatics. 2014;55(5):478-484. Summary: deep brain stimulation for parkinson disease has been associated with psychiatric adverse effects including anxiety, depression, mania, psychosis, and suicide. The purpose of this study was to evaluate the safety of deep brain stimulation in a large parkinson disease clinical practice. Patients approved for surgery by the (b)6) participated in a 6-month prospective naturalistic follow-up study. In addition to the unified parkinson's disease rating scale, stability and psychiatric safety were measured using the beck depression inventory, hamilton depression rating scale, and young mania rating scale. Outcomes were compared in patients with parkinson disease who had a psychiatric history to those with no co-morbid psychiatric history. The study was completed by 49 of 54 patients. Statistically significant 6-month baseline to end-point improvement was found in motor and mood scales. No significant differences were found in psychiatric outcomes based on the presence or absence of psychiatric comorbidity. Our study suggests that patients with parkinson disease who have a history of psychiatric co-morbidity can safely respond to deep brain stimulation with no greater risk of psychiatric adverse effect occurrence. A multidisciplinary team approach, including careful psychiatric screening ensuring mood stabilization and psychiatric follow-up, should be viewed as standard of care to optimize the psychiatric outcome in the course of deep brain stimulation treatment. Reported events: one patient with bilateral deep brain stimulation (dbs) for parkinson¿s disease experienced mania with psychotic features and required psychiatric hospitalization as a result. It was noted that the patient had no comorbidity prior to implant. The source literature did not include any specific device information. Further information has been requested; a supplemental report will be submitted if additional information is received.

 
Manufacturer Narrative

It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Correspondence has been sent to the author of the article inquiring about patient information and additional information regarding the reported events. Concomitant medical products: product id neu_unknown_lead, lot# unknown, product type lead. (b)(4).

 
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Brand NameUNKNOWN IMPLANTABLE NEUROSTIMULATOR
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 Key4792212
Report Number3007566237-2015-01407
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 05/05/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/22/2015
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
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/05/2015
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: 05/22/2015 Patient Sequence Number: 1
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