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 Cyst(s) (1800); Headache (1880); Nausea (1970); Vomiting (2144); Dysphasia (2195); Lethargy (2560); Unspecified Nervous System Problem (4426); Swelling/ Edema (4577)

Event Date 08/29/2020

Event Type  Injury  

Manufacturer Narrative

Fenoy aj, conner cr, withrow js, hocher aw.Case report of hyperacute edema and cavitation following deep brain stimulation lead implantation.Surg neurol int 2020;11:259.Doi: 10.25259/sni_527_2019.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.Information references the main component of the system.Other relevant device(s) are: product id: 3387, serial/lot #: unknown, ubd: unknown, implanted: unknown, explanted: n/a, udi#: asku.If information is provided in the future, a supplemental report will be issued.

Event Description

Summary: here, the authors report an unusual presentation of postoperative edema in a (b)(6)-year-old female who has bilateral dentatorubrothalamic tract (specifically, the ventral intermediate nucleus) dbs for a mixed type tremor disorder.Initial postoperative computed tomography (ct) was unremarkable and the patient was admitted for observation.She declined later on postoperative day (pod) 1 and became lethargic.Stat head ct scan performed revealed marked left-sided peri-lead edema extending into the centrum semiovale with cystic cavitation, and trace right-sided edema.On pod 2, the patient was alert, but with global aphasia, right-sided neglect, and a plegia right upper extremity.Corticosteroids were started and a complete infectious workup was unremarkable.She was intubated and ultimately required a tracheostomy and percutaneous gastrostomy tube.She returned to the clinic 3 months postoperatively completely recovered and ready for battery implantation.Conclusion: while this is an unusual presentation of cerebral edema following dbs placement, ultimately, the outcome was good similar to other reported cases.Supportive care and corticosteroids remain the treatment of cho ice for this phenomenon.Reported event: a (b)(6) year old female patient complained of headache with some nausea and vomiting on postoperative day (pod) 1.Surgery had been uncomplicated and the patient was interactive/conversant throughout.Head ct early on pod 1 was unremarkable and physical examination revealed no deficit, but the patient desired to stay overnight.Examination later on evening of pod 1 found her to be sleepy and lethargic.Stat head ct revealed marked left-sided peri-lead edema extending into the centrum semiovale with cystic cavitation and trace right-sided edema.Physical examination on morning of pod 2 revealed patient to be alert, but with global aphasia (i.E.Not following commands and not speaking), right sided neglect, and plegia right upper extremity.Corticosteroids (iv dexamethasone) were begun early on pod 2.The patient later became increasingly lethargic.She was intubated due to concerns for airway protection.Repeat head ct revealed increased edema.The hospital's critical care team was concerned for fulminant gas-producing bacterial infection as suggested by neuroradiology interpretation of cavitation surrounding one lead and strongly pushed for lead removal, which was resisted.Vancomycin and meropenem were empirically begun.Systemic tests for infection, including c-reactive protein, erythrocyte sedimentation rate, and white blood cell counts were normal, as well as blood cultures, which were negative at 24, 48 and 72 hours.The negative infectious workup and lack of change on serial repeat imaging disproved idea of infection.Acute venous infarction was considered, but radiological appearance of a cortical-subcortical typically wedge-shaped ischemic pattern was not present.The patient ultimately underwent tracheostomy and percutaneous endoscopic gastrostomy placement 6 days later, and was transferred to a rehabilitation facility on a steroid taper.She was subsequently discharged home on pod 40.At 3 months post-op, she was fully recovered and returned to clinic for extension and implantable neurostimulator (ins) placement.Follow-up ct scans showed significant resolution of per i-lead edema and cystic cavitation.See attached literature article.The following device information was identified in the article: lead model 3387.

• 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: 11060697
• MDR Text Key: 226120277
• Report Number: 2182207-2020-01543
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• 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: 12/01/2020
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR