MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number NEU_INS_STIMULATOR

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

Patient Problems Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Unspecified Infection (1930); Cognitive Changes (2551); Convulsion/Seizure (4406)

Event Date 08/13/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, lot# unknown, product type: lead.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, serial# unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown; product id: neu_unknown_lead, serial/lot #: unknown; product id: neu_unknown_lead, serial/lot #: unknown; product id: neu_ins_stimulator, serial/lot #: unknown; product id: neu_ins_stimulator, serial/lot #: unknown; product id: neu_ins_stimulator, serial/lot #: unknown; product id: neu_ins_stimulator, serial/lot #: unknown.Age/date of birth:.This value is the average age of the patients reported in the article as specific patients could not be identified.Age/date of birth.This value is the average age of the patients reported in the article as specific patients could not be identified.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

Nico golfrè andreasi, luigi michele romito, roberta telese, roberto cilia, antonio emanuele elia, alessio novelli, giovanni tringali, giuseppe messina, vincenzo levi, grazia devigili, sara rinaldo, angelo amato franzini, roberto eleopra.Short- and long-term motor outcome of stn-dbs in parkinson¿s disease: focus on sex differences.Doi:10.1007/s10072-021-05564-w abstract introduction subthalamic nucleus deep brain stimulation (stn-dbs) is an established treatment for patients with parkinson¿s disease (pd) with motor complications; the contribution of sex in determining the outcome is still not understood.Methods we included 107 patients (71 males) with pd consecutively implanted with stn-dbs at our center.We reviewed patient charts from our database and retrospectively collected demographical and clinical data at baseline and at three followup visits (1, 5 and 10 years).Results we found a long-lasting effect of dbs on motor complications, despite a progressive worsening of motor performances in the on medication condition.Bradykinesia and non-dopaminergic features seem to be the major determinant of this progression.Conversely to males, females showed a trend towards worsening in bradykinesia already at 1-year follow-up and poorer scores in non-dopaminergic features at 10-year follow-up.Levodopa equivalent daily dose (ledd) was significantly reduced after surgery compared to baseline values; however, while in males ledd remained significantly lower than baseline even 10 years after surgery, in females ledd returned at baseline values.Males showed a sustained effect on dyskinesias, but this benefit was less clear in females; the total electrical energy delivered was consistently lower in females compared to males.The profile of adverse events did not appear to be influenced by sex.Conclusion our data suggest that there are no major differences on the motor effect of stn-dbs between males and females.However, there may be some slight differences that should be specifically investigated in the future and that may influence therapeutic decisions in the chronic follow-up.Reported events: it was reported that 5 patients experienced seizures during the hospitalization after surgery.It was reported that 4 patients experienced symptomatic hemorrhage during the hospitalization.It was reported that 1 patient experienced cerebral infection during the hospitalization after surgery.It was reported that 3 patients experienced asymptomatic intracranial hemorrhage during the hospitalization after surgery.It was reported that 4 patients experienced delirium it was reported that 3 patients experienced psychosis it was reported that 1 patients experienced suicidal thoughts it was reported that 6 patients experienced hallucinations 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: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12965643
• MDR Text Key: 285685895
• Report Number: 2182207-2021-02128
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2021
• 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): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 73 KG