MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_INS_STIMULATOR

Device Problems High impedance (1291); Malposition of Device (2616)

Patient Problems Wound Dehiscence (1154); Erythema (1840); Hemorrhage/Bleeding (1888); Hemorrhage, Subdural (1894); Inflammation (1932); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Dyskinesia (2363); Bronchopneumonia (2437); Post Operative Wound Infection (2446)

Event Date 02/10/2020

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_ext, serial/lot #: unknown.Product id: neu_ins_stimulator, serial/lot #: unknown.Product id: neu_unknown_lead, 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 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.Nonaka m, morishita t, yamada k, et al.Surgical management of adverse events associated with deep brain stimulation: a single-center experience.Sage open med.2020;8:2050312120913458.10.1177/2050312120913458.If information is provided in the future, a supplemental report will be issued.

Event Description

Masani nonaka, takashi morishita, kazumichi yamada, shinsuke fujioka, masa-aki higuchi, yoshio tsuboi, hiroshi abe and tooru inoue summary: objectives: deep brain stimulation is widely used to treat movement disorders and selected neuropsychiatric disorders.Despite the fact, the surgical methods vary among centers.In this study, we aimed to evaluate our own surgical complications and how we performed surgical troubleshooting.Methods: a retrospective chart review was performed to evaluate the clinical data of patients who underwent deep brain stimulation surgery and deep brain stimulation¿related procedures at our center between october 2014 and september 2019.We reviewed surgical complications and how surgical troubleshooting was performed, regardless of where the patient underwent the initial surgery.Results: a total of 92 deep brain stimulation lead implantation and 43 implantable pulse generator replacement procedures were performed.Among the 92 lead implantation procedures, there were two intracranial lead replacement surgeries and one deep brain stimulation lead implantation into the globus pallidus to add to existing deep brain stimulation leads in the bilateral subthalamic nuclei.Wound revision for superficial infection of the implantable pulse generator site was performed in four patients.There was neither intracerebral hemorrhage nor severe hardware infection in our series of procedures.An adaptor (extension cable) replacement was performed due to lead fracture resulting from a head trauma in two cases.Conclusion: we report our experience of surgical management of adverse events associated with deep brain stimulation therapy with clinical vignettes.Deep brain stimulation surgery is a safe and effective procedure when performed by a trained neurosurgeon.It is important for clinicians to be aware that there are troubles that are potentially manageable with optimal surgical treatment.Reported events: it was reported that a (b)(6)-year-old underwent bilateral simultaneous stn dbs for pd.Their history was complicated with a lead replacement surgery due to lead misplacement on the left, but their pd symptoms on the right side of the body and severe dyskinesia were not resolved with surgery.They were referred to the department for troubleshooting at the age (b)(6).A ct scan revealed the misplaced lead position of the left dbs lead, and the left dbs was considered ineffective following thorough evaluation.Therefore, they underwent replacement of the existing left dbs lead with a new gpi dbs lead.Following surgery their on/off motor fluctuation and dyskinesia improved.It was reported a (b)(6)-year-old woman underwent bilateral stn dbs for pd at age (b)(6).The surgery was performed uneventfully, and the patient initially felt benefit from the dbs therapy.However, the patient gradually developed pd symptoms, especially dyskinesia that couldn't be suppressed either by medication or by stn stimulation that impaired their quality of life.Following careful discussion, they performed a rescue dbs lead implantation in the right gpi, as dyskinesia was worse on the left side of the body.Another burr hole was fashioned in addition to existing burr holes for their current stn dbs, and a dbs lead was placed in the gpi.The existing right stn lead was not explanted as preoperative evaluation showed some clinical benefit of the stimulation.The existing ipg was replaced with a dual-channel ipg and their dyskinesia was resolved following the surgery.3.It was reported that a (b)(6)-year-old pd patient underwent a right dbs system implantation uneventfully.Four months later they noticed inflammation of the left subclavian incisional site.They were then prescribed topical gentamicin.However symptoms progressed and redness and superficial hemorrhage developed.They went into the department 5 months later and underwent an urgent wound revision.4.It was reported that a (b)(6)-year-old woman underwent a left-sided unilateral gpi dbs for pd and was discharged uneventfully.They fell in their home 2 months following the surgery and suffered head trauma in the occipital area at the side of the extension cable behind their ear.They then felt sudden loss of benefit of dbs, as their on/off motor fluctuations became aggravated.The impedances were extraordinarily high at all contacts, and an x-ray revealed that the cable was fractured.Therefore, they underwent urgent replacement of the extension cable, which restored the benefits of the dbs.5.It was reported that there was one case that had a small chronic subdural hematoma incidentally found on a ct scan performed on postoperative day 10, but the hematoma was asymptomatic and resolved spontaneously.6.It was reported that two patients had postoperative hematoma in the subclavian pocket following ipg replacement, and underwent urgent wound revision.7.It was reported that two patients in the post-operative period after 30 days had superficial infections and wound revision was performed.8.It was reported that one patient had aspiration pneumonia in the early post-operation period.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10084152
• MDR Text Key: 201060916
• Report Number: 2182207-2020-00234
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2020
• Initial Date FDA Received: 05/22/2020
• 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: 62 YR