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

Model Number NEU_UNKNOWN_LEAD

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Convulsion/Seizure (4406)

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown ; product id: neu_ins_stimulator, serial/lot #: unknown ; product id: neu_ins_stimulator, serial/lot #: unknown.This value is the average age of the patients reported in the article as specific patients could not be identified.Sex :this value reflects the gender of the majority 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

Wong jk, viswanathan vt, nozile-firth ks, et al.Stn versus gpi deep brain stimulation for action and rest tremor in parkinson's disease.Front hum neurosci.2020;14:578615.10.3389/fnhum.2020.578615.The authors retrospectively reviewed the 1-year clinical outcome of pd patients treated with stn and gpi dbs at the university of florida.They specifically selected patients with moderate to severe at.Eighty-eight patients (57 stn and 31 gpi) were evaluated at 6 and 12 months for changes in at and rt in the off-medication/on stimulation state.A comparison of response was performed and defined as greater than or equal to a 2-point decrease in tremor score.Reported events: 6 instances of lead hardware issues were reported.1 instance of lead migration was reported.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: 11226285
• MDR Text Key: 247352765
• Report Number: 2182207-2021-00130
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_UNKNOWN_LEAD
• Device Catalogue Number: NEU_UNKNOWN_LEAD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2021
• 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 Age: 61 YR