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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

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MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M Back to Search Results
Model Number NEU_INS_STIMULATOR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dysphagia/ Odynophagia (1815); Muscular Rigidity (1968); Pain (1994); Dysphasia (2195); Discomfort (2330); Unspecified Nervous System Problem (4426); Insufficient Information (4580)
Event Date 08/18/2022
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: 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, 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.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Lin s, wang l, shu y, et al.Rescue procedure for isolated dystonia after the secondary failure of globus pallidus internus deep brain stimulation.Frontiers in neuroscience.2022;16:924617.10.3389/fnins.2022.924617.  globus pallidus internus (gpi) deep brain stimulation (dbs) is widely used in patients with dystonia.However, 10¿20% of patients receive insufficient benefits.The objectives of this study are to evaluate the effectiveness of bilateral subthalamic nucleus (stn) dbs along with unilateral posteroventral pallidotomy (pvp) in patients with dystonia who experienced unsatisfactory gpi-dbs and to address the reported rescue procedures after suboptimal dbs or lesion surgery in dystonia patients.Six patients with isolated dystonia who had previously undergone bilateral gpi-dbs with suboptimal improvement were included.Reported events: pli 10: one patient experienced cranial and cervical dystonia, along with dysarthria and dysphagia, requiring rescue surgery.  pli 20: one patient experienced involuntary blinking and worsening cervical dystonia requiring rescue surgery.Pli 30: one patient experienced left torticollis, neck pain and cervical stiffness requiring rescue surgery.Pli 40: one patient experienced a new symptom of shoulder stiffness requiring rescue surgery.Pli 50: one patient experienced blepharospasms, mouth movement and low speaking tone requiring rescue surgery.Pli 60: one patient experienced severe involuntary movement in arms, shoulders, neck and mouth requiring rescue surgery.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.
 
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Brand Name
IMPLANTABLE NEUROSTIMULATOR
Type of Device
IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
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 Key15753374
MDR Text Key303294532
Report Number2182207-2022-02078
Device Sequence Number1
Product Code MRU
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
H020007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberNEU_INS_STIMULATOR
Device Catalogue NumberNEU_INS_STIMULATOR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/10/2022
Initial Date FDA Received11/08/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age53 YR
Patient SexMale
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