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

Model Number NEU_INS_STIMULATOR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Intracranial Hemorrhage (1891); Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

Krauss p, oertel mf, baumann-vogel h, et al.Intraoperative neurophysiologic assessment in deep brain stimulation surgery and its im pact on lead placement.J neurol surg a cent eur neurosurg.2020.10.1055/s-0040-1716329.Other relevant device(s) are: product id: neu_ins_stimulator, serial/lot #: unknown.Product id: 3389, serial/lot #: unknown.Product id: neu_ins_stimulator, serial/lot #: unknown.Age: this value is the average age of the patients reported in the article as specific patients could not be identified.Sex: 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 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.If information is provided in the future, a supplemental report will be issued.

Event Description

Krauss p, oertel mf, baumann-vogel h, et al.Intraoperative neurophysiologic assessment in deep brain stimulation surgery and its im pact on lead placement.J neurol surg a cent eur neurosurg.2020.10.1055/s-0040-1716329 summary: deep brain stimulation (dbs) is a well-accepted and highly effective surgical treatment option for diverse neurological and psychiatric disorders.1¿8 the widest experience in dbs exists in movement disorders 3, 6 including parkinson¿s disease (pd), 1, 5, 7, 8 with significant improvement by dbs being shown in various clinical trials.The anatomical targets are usually small and deep seated, and the precise determination of the stimulation point is of utmost importance to optimize clinical outcome and minimize stimulation related side effects (srse).Despite the widespread use of dbs, techniques of intracranial lead placement differ widely among functional neurosurgeons.9 some centers perform electrophysiologic evaluation of the target region by microelectrode recording (mer).10¿12 additionally, intraoperative microstimulation (ms) during awake surgery can provide direct feedback on stimulation efficacy and potential srse.13 identified events: 1 patient suffered a cardiopulmonary decompensation.2 patients experienced hardware failures.4 patients experiences hemorrhages.3 patients experienced infections at the implantable neurostimulator (ins) site.The following device specifics were provided: lead model 3389.

• 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: 11096283
• MDR Text Key: 225471708
• Report Number: 2182207-2020-01576
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• 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: 12/03/2020
• 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