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

Model Number NEU_INS_STIMULATOR

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

Patient Problems Wound Dehiscence (1154); Erosion (1750); Purulent Discharge (1812); Fistula (1862); Staphylococcus Aureus (2058)

Event Date 03/31/2020

Event Type  Injury  

Manufacturer Narrative

Patient ages are available.Date of event: 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.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Concomitant medical products: product id: neu_unknown_lead, serial/lot #: unknown.Product id: neu_ins_stimulator, serial/lot #: unknown.Product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Tanaka h, rikimaru h, rikimaru-nishi y, et al.Surgical management of deep brain stimulator infection without electrode removal: report of two cases.J neurol surg rep.2020;81(1):e15-e19.10.1055/s-0039-3399569.Summary: stimulation of the subthalamic nucleus by implanted electrodes (deep brain stimulation [dbs]) is performed to suppress symptoms of parkinson¿s disease.However, postoperative wound dehiscence and infection can require removal of the implanted electrode leads.This report describes treatment of intractable unilateral wound infection in two patients without removing the dbs device.First, components of the dbs system were removed except for the electrode lead and thorough debridement of the infected wound was conducted.Second, the edges of the bone defect left by removal of dbs components were smoothed to eliminate dead space.Subsequently, the electrode lead was covered by using a pericranial-frontalis-muscle flap or a bi-pedicled-scalp flap with good blood supply.Closed intrawound continuous negative pressure and irrigation treatment was conducted for 1 week after the surgery, and then the drain was removed.The authors treated two patients with wound infection after implantation of dbs electrodes.Case 1 developed a cutaneous fistula and case 2 had wound dehiscence.After treatment by the method described above, complete wound healing was achieved in both patients.Dbs is always associated with a risk of infection or exposure of components and treatment can be very difficult.The authors successfully managed intractable wound infection while leaving the electrode lead in situ, so that it was subsequently possible to continue dbs for parkinson¿s disease.Reported events: a (b)(6) year old female patient implanted with deep brain stimulation (dbs) for parkinson's disease (pd) developed a cutaneous fistula at 6 months post lead placement.The infectious agent was determined to be (b)(6).The patient was transferred to another department due to persistence of fistula.At initial exam, a cutaneous fistula was seen in the forehead scar, pus drainage was observed, and the burr hole cover cap was visible in the fistula.The wound was re-opened along the previous incision line.Infected granulation tissue was detected around the burr hole cover and along the lead.The burr hole cover was removed, but the lead was left in situ to continue dbs therapy.Debridement of the infected granulation tissue was performed and the edges of the bone defect left after component removal were smoothed.A pedicled pericranial frontalis muscle flap was harvested from the parietal region on the healthy (right) side, and was used to cover the lead and fill the dead space in the bone defect.The edges of the debrided fistula showed very poor circulation.Because the pericranial flap was placed under the fistula, there was no bone exposure; hence, healing by secondary intention was deemed possible and the fistula was left open without suturing.To prevent post-operative infection, two drains were placed between the pericranial flap and the bone.Closed intrawound continuous negative pressure and irrigation treatment (iw-conpit) was initiated at 2,000 ml/d.After conducting iw-conpit for 1 week, the drains were removed since there was no sign of infection.The fistula showed epithelialization by 2 weeks and there was no relapse of fistula or infection during follow-up for 1.5 years.A (b)(6) year old female patient implanted with dbs for pd developed wound dehiscence at four months post lead implant.The infectious agent was determined to be (b)(6).At initial examination, pus drainage from a cutaneous fistula and exposure of the burr hole cover were observed.A fusiform skin incision was made to resect the cutaneous fistula, revealing the old surgical wound was filled with infected granulation tissue.The burr hole cover cap was removed while retaining the lead.Debridement of infected granulation tissue was performed and the edges of the bone were smoothed.The wound was closed using a bi-pedicled flap raised from the right side, while the donor site was covered with a skin graft.Closed iw-conpit was initiated immediately after surgery and continued for one week.Drains were removed due to no signs of infection at that time.At one year and 7 months, there was no recurrence of fistula or infection.No specific device information could be identified in the article.

• 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: 10078932
• MDR Text Key: 200961393
• Report Number: 2182207-2020-00238
• 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: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2020
• 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