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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 Type  Death  
Event Description

Thavanesan, n. , gillies, m. , farrell, m. , green, a. L. , aziz, t. Deep brain stimulation in multiple system atrophy mimicking idiopathic parkinson's disease. Case reports in neurology. 2014;6(3):232-237. Doi: 10. 1159/000368571. Summary: deep brain stimulation (dbs) is approved for idiopathic parkinson¿s disease (ipd) but has a poor evidence base in parkinson-plus syndromes such as multiple system atrophy (msa). We describe the clinical and neuropathological findings in a man who was initially diagnosed with ipd, in whom dbs was unsuccessful, and in whom msa was unexpectedly diagnosed at a subsequent autopsy. This case report highlights that dbs is often unsuccessful in msa and also demonstrates that msa can masquerade as ipd, which may explain treatment failure in a small group of patients apparently suffering from parkinson¿s disease. Additionally, it also presents a case with an unusually long duration of disease prior to death, comparable only to a handful of other cases in the literature. Reported event: one (b)(6) male patient underwent 2-stage bilateral deep brain stimulation (dbs) implant for parkinson¿s disease in (b)(6) 2008. Stage 1 initially gave positive results barring an episode of confusion, hypotension and reduced glasgow coma scale (gcs) score attributed to overstimulation. Titration was effective, and the patient was switched from regular madopar to prn. Stage 2 was complication free aside from transient calibration paresthesia. Medications were stopped two days postoperatively with good gait, no tremor, no freezing and improved left arm mobility. A health care provider (hcp) and the patient specifically reported improvement in rigidity and gait. The patient was discharged three days later. The patient subsequently deteriorated after two weeks, returning to pre-operative medication doses, with his symptoms worse than preoperatively. The patient experienced confusion, short-term memory impairment and hypertonia in the left arm. Subsequent titration helped minimally. In the subsequent four years until time of death, the patient developed episodes of psychosis, dopamine dysregulation syndrome, iga nephropathy, chronic renal failure and ultimately terminal clostridium difficile colitis. Neuropathological examination, performed six years after surgery during the patient¿s autopsy, confirmed the placement of dbs electrodes in the subthalamic nucleus (stn). The neuropathological findings were those of multiple system atrophy (msa). The pathological diagnosis was based on extensive striatal and subcortical white matter accumulation of ¿-synuclein coupled with profound depletion of the neurons from the striatum and substantia nigra with atrophy and gliosis. Oligodendroglial ¿-synuclein inclusions were also very extensive in cerebral and cerebellar white matter, and the middle cerebellar peduncle also showed prominent ¿-synuclein-positive glial inclusions indicating elements of both a striatonigral and olivopontocerebellar pattern of distribution. Noteworthy was the finding of prominent ¿-synuclein-positive glial inclusions adjacent to the dbs insertion site in the stn. It was noted that incorrect preoperative idiopathic parkinson¿s disease diagnose showed positive initial response to surgery followed by rapid decline secondary to progression of msa and subsequent death. 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

Date of death: please note the patient's date of death was unavailable at the time of report. The date reported reflects the date the attached literature article was published online. Other: psychosis. 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 individual patient information and additional information regarding the reported events. Concomitant medical products: product id neu_unknown_lead, lot# unknown, product type: lead. (b)(4).

 
Manufacturer Narrative

Additional review of this event determined that the patient's death was related to the patient's disease (msa) progression and was not related to the dbs device or therapy. Additionally, the authors concluded that the dbs was inappropriate in treating multiple system atrophy (msa). The use of dbs was off label and it was not discovered until after postmortem pathological diagnosis was made. (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 Key4521234
Report Number3007566237-2015-00373
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/26/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/17/2015
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 Received02/23/2015
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: 02/17/2015 Patient Sequence Number: 1
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