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

Model Number NEU_INS_STIMULATOR

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

Patient Problems Adhesion(s) (1695); Pain (1994); Insufficient Information (4580)

Event Date 01/06/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_ext, serial#: unknown, product type: extension, product id: neu_ ins_stimulator, serial#: unknown, product type: implantable neurostimulator.Other relevant device(s) are: product id: neu_unknown_ext, serial/lot #: unknown.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

Patricia krause, daniel kroneberg, doreen gruber, kristin koch, gerd-helge schneider, andrea a.Kühn.Long-term effects of pallidal deep brain stimulation in tardive dystonia: a follow-up of 5¿14 years.Journal of neurology.Doi: 10.1007/s00415-022-10965-8.Abstract introduction pallidal dbs is an established treatment for severe isolated dystonia.However, its use in disabling and treatment-refractory tardive syndromes (ts) including tardive dyskinesia and tardive dystonia (td) is less well investigated and long-term data remain sparse.This observational study evaluates long-term effects of deep brain stimulation (dbs) of the globus pallidus internus (gpi) in patients with medically refractory ts.Methods we retrospectively analyzed a cohort of seven td patients with bilateral gpi-dbs.Involuntary movements, dystonia and disability were rated at long-term follow-up (lt-fu) after a mean of 122±33.2 sd months (range 63¿171 months) and compared to baseline (bl), short-term (st-fu; mean 6±2.0 sd months) and 4-year follow-up (4y-fu; mean 45±12.3 sd months) using the abnormal involuntary movement scale (aims) and the burke¿fahn¿marsden dystonia rating scale (bfmdrs), respectively.Quality of life and mood were evaluated using the sf36 and beck depression index (bdi) questionnaires, respectively.Results at lt-fu patients had improved by 73%±14.2 sd in involuntary movements and 90%±1.0 sd in dystonia.Mood had improved significantly whereas quality of life remained unchanged compared to baseline.No serious long-lasting stimulation-related adverse events (aes) were observed.Three patients of this cohort presented without active stimulation and ongoing symptom relief at long-term follow-up after 3¿10 years of continuous dbs.Conclusion pallidal dbs is a safe and effective long-term td treatment.Even more interesting, three of our patients could stop stimulation after several years of dbs without serious relapse.Larger studies need to explore the phenomenon of ongoing symptom relief after dbs cessation.Reported events: it was reported that one patient implanted with pallidal dbs for severe isolated dystonia had their ins explanted 8 years after implantation due to symptoms remission.It was reported that one patient implanted with pallidal dbs for severe isolated dystonia required surgical intervention due to intolerable pain and tension alongside their lead wires.It was reported that one patient implanted with pallidal dbs for severe isolateddystonia had transient stimulation-related dysarthria and gait disturbances remitting after stimulation parameter adjustments.No long term side effects such as bradykinesia or gait disturbances were observed in the cohort.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: 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 Key: 13896176
• MDR Text Key: 293154334
• Report Number: 2182207-2022-00506
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H020007
• 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: 03/24/2022

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 Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/24/2022
• 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