MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number NEU_INS_STIMULATOR

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/27/2018

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth.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 the date that the article was accepted for publication as the event dates were not provided in the published literature.The main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.Product id: neu_unknown_ext, serial/lot #: unknown.Deng, z., pan, y., zhang, c., zhang, j., qiu, x., zhan, s., li, d., sun, b.Subthalamic deep brain stimulation in patients with primary dystonia: a ten-year follow-up study.Parkinsonism relat disord.2018.Doi: 10.1016/j.Parkreldis.2018.05.024.If information is provided in the future, a supplemental report will be issued.

Event Description

Summary: background: subthalamic deep brain stimulation (stn-dbs) is a promising intervention for primary dystonia; however, evidence regarding its efficacy is lacking.Thus, a long-term follow-up is indispensable.Objective: this trial was designed to examine the efficacy and consistency of subthalamic deep brain stimulation in patients with primary dystonia over the long term.Method: this was a retrospective study involving 14 patients with primary dystonia who underwent stn-dbs and consented to a follow-up of at least 10 years.The burke-fahn-marsden dystonia rating scale (bfmdrs) and 36-item short-form general health survey were employed, at five time points (pre-operation [baseline], 1 month post-operation, 1 year post-operation, 5 years post-operation, and last follow-up), to assess improvement of dystonic symptoms and changes in quality of life.Outcomes: all patients gained extensive clinical benefits from stn-dbs therapy, without experiencing serious adverse effects.Improvements of 59.0% at 1 month, 85.0% at 1 year, and 90.8% at 5 years after the operation, and up to 91.4% at the last follow-up, were demonstrated by movement evaluation with the bfmdrs.All patients achieved a substantial improvement in quality of life.Conclusion: subthalamic deep brain stimulation is an effective and persisting alternative to pallidal deep brain stimulation, and importantly, it is very safe even with extremely long-term chronic stimulation.Reported events: 1.2 patients with bilateral stn-dbs for primary dystonia experienced electrode displacement.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: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7795173
• MDR Text Key: 117859462
• Report Number: 3007566237-2018-02473
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2018
• Initial Date FDA Received: 08/17/2018
• 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: 30 YR