MAUDE Adverse Event Report: RICE CREEK MFG 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 Fatigue (1849); Muscle Weakness (1967); Nausea (1970); Paresis (1998); No Code Available (3191)

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

Albano l, rohatgi p, kashanian a, bari a, pouratian n.Symptomatic pneumocephalus after deep brain stimulation surgery: report of 2 cases.Stereotact funct neurosurg.2020:1-7.10.1159/000505078.Date of event: please note that this date is based off of the date that the article was accepted for publication 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.Medical device information references the main component of the system.Other relevant device(s) are: product id: 3387, serial/lot #: unknown, implanted: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Reported event a (b)(6) year old female patient implanted with bilateral internal globus pallidus (gpi) deep brain stimulation (dbs) for parkinson's disease experienced post-operative symptomatic pneumocephalus.Patient's post-operative neurological examination was stable.Post-operative brain ct showed intraparenchymal air surrounding the superior portion of the right lead and significant bilateral subdural frontal pneumocephalus.The intraparenchymal air volume around the lead was 4.3 cc and subdural air volume was 49.8 cc.The patient was doing well the morning of the first post-op day, and was discharger home.Later that day, she had persistent fatigue and nausea, per family.On post-op day 5, the patient had left sided weakness.On examination, the patient was alert and oriented with a 3/5 left hemiparesis.A head ct demonstrated increase of pneumocephalus volume around right lead (19 cc) with compression of cortical brain parenchyma.The patient was taken to the or for pneumocephalus evacuation, irrigation, and wound revision.The burr hole cover was removed while manually holding the lead in position.The cavity surrounding the lead was washed out with sterile saline.The burr hole cover was re-secured and the cap replaced.The wound was closed in layers "in the usual fashion." the operation was well tolerated by the patient and she was weaned from non-rebreather oxygen mask over 5 days.The brain ct scan before discharge showed pneumocephalus resorption, with volume of air around the lead at 7.22 cc and no subdural air.Examination on discharge showed recovery with symmetric strength.At 6 month follow-up, more on-time and decreased dyskinesias with activation of dbs system was demonstrated.The following device specifics were identified in the literature article: lead model 3387.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was noted that a fibrin burr hole sealant was used to minimize risk of pneumocephalus.The authors noted it was possible that positioning the patient in a semi-recumbent position, with head-of-bed elevated at approximately 20-30 degrees may have contributed to the development of pneumocephalus, but it was difficult to determine the exact cause of the issue.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): RICE CREEK MFG; 7000 central ave ne; fridley MN 55432
• MDR Report Key: 9830005
• MDR Text Key: 191978320
• Report Number: 6000030-2020-00137
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• 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
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR