• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC NEUROMODULATION DEEP BRAIN STIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number NEU_INS_STIMULATOR
Device Problem Malposition of device
Event Date 01/01/2012
Event Type  Injury  
Event Description

Literature: ullman, michael, vinata vedam-mai, andrew s. Resnick, anthony t. Yachnis, nikolaus r. Mcfarland, stacy merritt, pamela z eilman, kelly d. Foote, and michael s. Okun. "deep brain stimulation response in pathologically confirmed cases of multiple system atrophy. " parkinsonism and related disorders 18 (2012): 86-88. Print. Summary: deep brain stimulation is a treatment for select cases of medication refractory movement disorders including parkinson's disease. Deep brain stimulation has not been recommended for treatment in multiple system atrophy patients. However, the paucity of literature documenting the effects of deep brain stimulation in multiple system atrophy patients and the revelation of a levodopa responsive subtype of multiple system atrophy suggests further investigation is necessary. This study summarizes the positive and negative effects of deep brain stimulation treatment in two pathologically confirmed multiple system atrophy patients from the (b)(6) deep brain stimulation-brain tissue network. Clinical diagnosis for the two patient cases did not match the neuropathological diagnosis. We noted that in both pathologically confirmed multiple system atrophy patients, death occurred as a result of myocardial infarction. Importantly, there was reported transient benefit in levodopa responsive features that indicate deep brain stimulation may be an option for select multiple system atrophy patients. Reported events: the patient underwent a dbs implantation on the left side in the globus pallidus internus (gpi) in (b)(6) 2004. The measured lead tip location for the left lead was -24. 6, -0. 5, -3. 6 (x,y,z), and was felt to be lateral to the optimal position. Following surgery the patient developed expressive aphasia which resolved over several weeks with therapy. The patient later developed a worsening gait. A brain mri revealed a lacunar infarct in the pallidum/internal capsule region. The left gpi_dbs and stroke reportedly improved his right hemibody parkinsonian symptoms. Although the dbs lead was sub-optimally placed, the infarct may have offered a beneficial lesion effect. The patient underwent right gpi-dbs implantation and repositioning of his left dbs lead in (b)(6) 2005. The measured lead tip location for the right lead was 22. 19, 4. 79, -2. 5 (x,y,z), and the measured lead tip location for the revised left lead was -20. 69, 7. 2, 11. 5 (x,y,z). The left lead was dorsally placed anterior and shallow to the optimal location, but the patient reported satisfactory improvement in his symptoms. Complications after the second dbs procedure included worsening of his speech intelligibility and pronounced sialorrhea. It was unclear from the dbs-btn notes whether this was direct result of surgery, or due to natural disease progression. The patient expired at the (b)(6) from a myocardial infarction. He showed no early cardiac problems, but pathologic evaluation revealed arterial/arteriolar sclerosis. Further information has been requested; a supplemental report will be submitted if additional information is received.

 
Manufacturer Narrative

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. Continued concomitant medical products: neurostimulator model unknown serial# unknown implanted: unknown explanted: unknown; lead model unknown lot# unknown implanted: unknown explanted: unknown; lead model unknown lot# unknown implanted: unknown explanted: unknown. (b)(6).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEEP 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 55431
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis , MN 55431
7635263987
MDR Report Key2484883
Report Number3007566237-2012-00503
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 02/16/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/09/2012
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
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/16/2012
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: 03/09/2012 Patient Sequence Number: 1
-
-