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

Model Number NEU_INS_STIMULATOR

Device Problems Difficult to Remove (1528); Device Or Device Fragments Location Unknown (2590)

Patient Problems Wound Dehiscence (1154); Erosion (1750); Dysphagia/ Odynophagia (1815); Edema (1820); Intracranial Hemorrhage (1891); Unspecified Infection (1930); Pocket Erosion (2013); Dysphasia (2195)

Event Type  Injury  

Manufacturer Narrative

Takeda, n., horisawa, s., taira, t., kawamata, t.Radiofrequency lesioning through deep brain stimulation electrodes in patients with generalized dystonia.World neurosurgery.2018; 115: 220-224.Doi: 10.1016/j.Wneu.2018.04.055.Ages of the specific patients; sexes of the specific patients; event dates of the specific events see report.Please note, only the years of the events were provided in the literature article.The year of the implant and explant dates below are valid, but the month/year is unknown as the literature article did not report specific implant/explant dates.Product id 3387, implanted: (b)(6) 2008, product type lead.Product id neu_unknown_ext, implanted: (b)(6) 2004, explanted: (b)(6) 2006, product type extension.Product id 3387, implanted: (b)(6) 2004, explanted: (b)(6) 2006, product type lead.Product id neu_ins_stimulator, implanted: (b)(6) 2009, explanted: (b)(6) 2013, product type implantable neurostimulator.Product id neu_unknown_ext, implanted: (b)(6) 2009, explanted: (b)(6) 2013, product type extension.Product id 3387, implanted: (b)(6) 2009, explanted: (b)(6) 2013, product type lead.Product id neu_ins_stimulator, implanted: (b)(6) 2006, explanted: (b)(6) 2013, product type implantable neurostimulator, product id neu_unknown_ext, implanted: (b)(6) 2006, explanted: (b)(6) 2013, product type extension.Product id 3387, implanted: (b)(6) 2006, explanted: (b)(6) 2013, product type lead.Product id neu_ins_stimulator, implanted: (b)(6) 2008, explanted: (b)(6) 2009, product type implantable neurostimulator.Product id neu_ins_stimulator, implanted: (b)(6) 2009, explanted: (b)(6) 2012, product type implantable neurostimulator.Product id neu_unknown_ext, implanted: (b)(6) 2008, explanted: (b)(6) 2012, product type extension.Product id 3387, implanted: (b)(6) 2008, explanted: (b)(6) 2012, product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 3387; product id: neu_unknown_ext; product id: 3387; product id: neu_ins_stimulator; product id: neu_unknown; product id: 3387; product id: neu_ins_stimulator; product id: neu_unknown_ext; product id: 3387; product id: neu_ins_stimulator; product id: neu_ins_stimulator; product id: neu_unknown_ext ; product id: 3387.If information is provided in the future, a supplemental report will be issued.

Event Description

Summary: deep brain stimulation (dbs) is an established treatment for generalized dystonia.However, the dbs device is sometimes removed owing to hardware complications.The authors present 4 cases of generalized dystonia treated with radiofrequency lesioning through dbs electrodes.Four patients, 3 men and 1 woman (age range, 34-44 years), underwent dbs for generalized dystonia and subsequently developed complications, such as infection, necessitating removal of the devices.As stopping the stimulation caused recurrence of uncontrollable symptoms, radiofrequency lesioning was performed through the dbs electrodes under local anesthesia, and the dbs systems were removed under local or generalized anesthesia thereafter.The procedures performed were as follows: 2 patients had bilateral pallidotomy, 1 patient had unilateral pallidotomy, and 1 patient had pallidotomy and ipsilateral thalamotomy.As a result, in 4 patients, the dystonic symptoms did not worsen even after removal of the dbs systems during a follow-up period of 1-12 years.However, 1 patient had a small hemorrhage, and 2 patients showed recurrence of dystonia.Radiofrequency lesioning with dbs electrodes is feasible in cases of generalized dystonia when the dbs leads have to be removed.Reported events: patient 4: a (b)(6) male patient implanted with bilateral gpi leads underwent bilateral pallidotomy through the dbs leads.Just after coagulation occurred, the lead could not be removed because of resistance that was felt.The physicians thought that charring between the brain tissue and the lead had occurred, so part of the lead was left in place.Postoperative ct revealed bilateral perifocal edema and a small hemorrhage in the right lesion, which led to dysarthria and swallowing difficulties.These complications gradually improved with rehabilitation, and the patient was discharged from the hospital.Patient 1: a (b)(6) male patient implanted with bilateral globus pallidus (gpi) deep brain stimulation (dbs) for cervical and truncal dystonia experienced a wound infection in 2005.Debridement and re-suturing were performed, but were ineffective, and the devices were removed without replacement a year later.Patient 2: a (b)(6) female patient implanted with bilateral gpi dbs for truncal dystonia experienced infection of the lead in 2012.Debridement was performed, but the infection recurred in 2013, and the devices were completely removed without replacement.Patient 3: a (b)(6) male patient implanted with bilateral dbs in the left gpi and left ventralis oralis anterior for cervical dystonia and strabismus experienced a right ins exposure and wound disruption in 2012.Debridement and re-suturing were performed, but wound disruption recurred the following year.The bilateral ins was moved to another position, but, in the same year, the left ins was exposed again.The device was finally removed, and not replaced.The patient's infection has since been controlled.Patient 4: a (b)(6) male patient implanted with bilateral gpi dbs experienced right ins exposure in 2009, so the device was removed and later replaced after gaining control over the infection.Patient 4: a (b)(6) male patient implanted with bilateral gpi dbs experienced lead exposure in the left hand side of the neck in 2012.Wound debridement and re-suturing were performed, but the wound expanded to bilateral sides, and a focal infection also occurred.The dbs device was removed, and not replaced.Additional relevant medical history included: patient 2: bilateral blepharospasm, meige syndrome, retrocollis patient 3: hemidystonia, idiopathic primary dystonia patient 4: depression, psychotropic medication, retrocollis, and truncal back bending see attached literature article.The following device specifics were provided: lead model 3387.

Manufacturer Narrative

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

Manufacturer Narrative

Supplemental sent for coding update following additional review.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: 7647676
• MDR Text Key: 112708301
• Report Number: 3007566237-2018-01928
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• 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: 08/13/2018
• 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): Hospitalization; Other; Required Intervention