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

Model Number NEU_UNKNOWN_LEAD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dementia (1808); Intracranial Hemorrhage (1891)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

Event Description

Francesco bove, valerie fraix, francesco cavallieri, emmanuelle schmitt, eugenie lhommee, amelie bichon, sara meoni, pierre pelissier, andrea kistner, erick chevrier, claire ardouin, patricia limousin, paul krack, alim louis benabid, stephan chabardes, eric seigneuret, anna castioto, elena moro.Dementia and subthalamic deep brain stimulation in parkinson's disease.Doi:10.1212/wnl.0000000000009822.Abstract objectives to assess the prevalence and the cumulative incidence of dementia at short-, medium- and long-term follow-up after deep brain stimulation (dbs) of the subthalamic nucleus (stn) (at 1, 5, and 10 years) and to evaluate potential risk factors for postoperative dementia.Methods the presence of dementia (according to the dsm-v) was retrospectively evaluated at each postoperative follow-up in patients with parkinson disease (pd) who underwent bilateral stndbs.Preoperative and perioperative risk factors of developing postoperative dementia were also investigated.Demographic data, disease features, medications, comorbidities, nonmotor symptoms, pd motor scales, neuropsychological scales at baseline, and perioperative complications were collected for each patient.Results a total of 175 patients were included, and 104 were available at 10-year follow-up.Dementia prevalence was 2.3% at 1 year, 8.5% at 5 years, and 29.8% at 10 years.Dementia cumulative incidence at 1, 5, and 10 years was 2.3%, 10.9%, and 25.7%, respectively.The corresponding dementia incidence rate was 35.6 per 1,000 person-years.Male sex, higher age, hallucinations, lower frontal score at baseline, and perioperative cerebral hemorrhage were predictors of dementia.Conclusions in patients with pd with long standing stn-dbs, dementia prevalence and incidence are not higher than those reported in the general pd population.Except for few patients with perioperative cerebral hemorrhage, stn-dbs is cognitively safe, and does not provide dementia risk factors in addition to those reported for pd itself.Identification of dementia predictors in this population may improve patient selection and information concerning the risk of poor cognitive outcome.Pli 10: it was reported that 5 patient's experienced cerebral hemorrhage perioperatively and had developed dementia.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.

• Brand Name: LEAD
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10451972
• MDR Text Key: 210695875
• Report Number: 2182207-2020-00764
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_UNKNOWN_LEAD
• Device Catalogue Number: NEU_UNKNOWN_LEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other