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

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); High impedance (1291); Migration or Expulsion of Device (1395); Unstable (1667); Low impedance (2285)

Patient Problems Erosion (1750); Hematoma (1884); Intracranial Hemorrhage (1891); Hemorrhage, Subdural (1894); Unspecified Infection (1930); Muscular Rigidity (1968)

Event Date 08/04/2019

Event Type  Injury  

Manufacturer Narrative

This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.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.Section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown ; product id: neu_ins_stimulator, serial/lot #: unknown, ; product id: neu_unknown, serial/lot #: unknown ; product id: neu_unknown, serial/lot #: unknown ; product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#: ; product id: neu_ins_stimulator, serial/lot #: unknown ; product id: neu_unknown_ext, serial/lot #: unknown; product id: neu_ins_stimulator, serial/lot #: unknown, (b)(6).Pre-operative smoking history increases risk of infection in deep brain stimulation surgery.J clin neurosci.2019.10.1016/j.Jocn.2019.08.026.If information is provided in the future, a supplemental report will be issued.

Event Description

Abstract: although general risk of deep brain stimulation (dbs) therapy has been previously described, application of risk prediction at the individual patient level is still largely at the discretion of a treating physician or a multidisciplinary team.To explore associations between potentially modifiable patient characteristics and common adverse events following dbs surgery, we retrospectively reviewed consecutive adult patients who had undergone new dbs electrode placement surgeries at two high-volume tertiary referral centers between october 1997 and may 2018.Among 501 patients included in the analysis (mean age (sd), 64.6 (10.4) years), (b)(4) were female, (b)(4) had diabetes, (b)(4) had hypertension, (b)(4) were smokers, (b)(4) developed an infection, (b)(4) had intracranial or intraventricular hemorrhage, and (b)(4) had an unplanned return to the operating room.Patients who developed a surgical site infection were more likely to report history of smoking before dbs surgery (b)(4).There was a trend for patients with hypertension to be at risk for intracranial hemorrhage (p = 0.11).In conclusion, this multicenter study demonstrated an association between preoperative smoking and increased risk of infection following new dbs implantation surgery.Counseling about this risk should be considered in preoperative evaluation of patients who are considering undergoing a dbs procedure.Reported events for patients with parkinson's disease: (b)(4) patients with a mean age of 64 years old reported infection.Infection was defined as a patient requiring either surgical removal of dbs hardware or medical treatment, and were either perioperative (occurring within 3 months of lead implant) or delayed.(b)(4) patients with a mean age of 66 years old reported intracranial hemorrhage, all of them associated with lead implantation.This included intraparenchymal hemorrhage along the lead, and subdural hematoma.Up to 34 patients with a mean age of 64 returned to the operating room for reasons including erosion of hardware, fracture of hardware detected as short circuit or open circuit or on imaging, revision of lead location, revision of flipping or loose generator, or tight extension wires.The following device specifics were mentioned: lead models 3387 and 3389.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 9158745
• MDR Text Key: 168016610
• Report Number: 3007566237-2019-02078
• 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: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• 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
• Date Manufacturer Received: 09/24/2019
• 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; Required Intervention
• Patient Age: 65 YR