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

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); Fracture (1260); Insufficient Information (3190)

Patient Problems Death (1802); Dysphagia/ Odynophagia (1815); Muscle Spasm(s) (1966); No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

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.The device was used for an off label indication; information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead; product id: neu_unknown_lead.Gonzalez, v., cif, l., milesi, c., cambonie, g., de antonio rubio, i., cyprien, f., chan seng, e., roujeau, t., coubes, p.Long-term clinical outcome of deep brain stimulation in pkan syndrome.European journal of paediatric neurology (2017) 21 supplement 1 (e179).If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

Abstract: objective: to describe long-term clinical outcome of a series of patients suffering from pkan syndrome treated with deep brain stimulation (dbs).Pkan syndrome is an autosomal recessive neurodegenerative disorder secondary to pank2 gene mutations, manifesting by severe generalized dystonia and spasticity.Classical childhood-onset phenotype is often associated with fatal outcome.To date, several case reports have been published to describe the therapeutic outcome of globus pallidus internus (gpi) and more recently subthalamic nucleus dbs in pkan syndrome.No pharmacological treatment has yet been approved to treat this condition.Methods: we conducted a retrospective systematic review of patients with documented diagnosis of pkan syndrome treated with dbs in our center.Clinical outcome was measured with bfmdrs scale.All patients were implanted with mri-guided targeting without microelectrode recordings.Results: we identified 18 patients in our database corresponding to inclusion criteria: 5 adults and 13 children (m:f =10:8).Age at surgery was 28.601 ± 7 years for adults and 11.9 ± 2.6 for children.All patients underwent gpi dbs; 5 patients were implanted with a second pair of leads during follow-up (thalamic vim/vop target (n = 4) and stn (n = 1)).Intrathecal baclofen pump was used to treat severe associated spasticity in 4 patients.Four patients required tube feeding due to severe dysphagia.Postoperative clinical management was complicated by several device-related adverse events: lead fracture, lead dysfunction (7 patients).Six patients developed status dystonics.Five patients died despite intensive care unit management and advanced surgical therapies (2.8 ± 2 yr after surgery).Mean follow-up after surgery for the other patients was 10.9 ± 4.6 years.Conclusion: gpi dbs was effective in long-term treatment of severe dystonia in pkan syndrome in our series (mean follow-up: 8.6 years).Classical childhood-onset of disease and severe gpi atrophy were associated with a more severe clinical condition with high prevalence of status dystonics despite dbs therapy.Reported events: 1 patient who was implanted with gpi-dbs for pkan experienced lead fracture.7 patients who were implanted with gpi-dbs for pkan experienced ¿lead dysfunction.¿ it was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 7695710
• MDR Text Key: 114693995
• Report Number: 3007566237-2018-02120
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• 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
• Date Manufacturer Received: 08/08/2018
• 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 Age: 17 YR