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

Model Number NEU_INS_STIMULATOR

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930); Meningitis (2389); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2022

Event Type  Injury  

Event Description

Onder taskin, ersoy kocabicak, sait ozturk, onur yildiz, yasin temel.Turk neurosurg.Electrode fixation with bone cement or stimloc® in deep brain stimulation surgery: a comparative study.Doi: 10.5137/1019-5149.Jtn.35635-21.2.Aim: to examine the postoperative outcomes of electrode fixation using bone cement and stimloc® in patients with parkinson¿s disease (pd) who underwent subthalamic nucleus (stn) deep brain stimulation (dbs).Material and methods: between 2016 and 2018, perm anent electrode fixation was performed in 30 patients with pd, of which 15 received bone cement and the remaining 15 received stimloc®.Data regarding preoperative unified parkinson¿s disease rating scale (updrs) iii scores, levodopa equivalent daily dose (ledd) values, surgery duration, and the fixation technique used were recorded.Brain computed tomography was performed for early postoperative evaluation of pneumocephalus and possible hematoma as well as for the determination of migration 1 year postoperatively.Updrs iii scores and ledd values were re-evaluated 1 year postoperatively; surgery duration, clinical effectiveness, and complication rates were compared between the two fixation techniques.Results: a statistically significant difference in application time was observed between the two techniques (bone cement: 21 min, stimloc®: 6 min).After 1 year from surgery, 0.92- and 0.88-mm migrations were observed in the bone cement and stimloc® groups, respectively.A significant correlation between migration and the pneumocephalus volume was observed in both groups.No differences were observed between the groups regarding infection, migration, pneumocephalus volume, wound erosion, and clinical outcomes.Conclusion: stimloc® is preferred over bone cement for electrode fixation in dbs surgeries as it is associated with shorter application duration; this increases patient comfort and tolerance during awake surgery.Clinical efficacy and complication rates associated with both techniques are similar.Reported events: 1.It was reported that 2 patient's implanted for parkinson's disease that underwent bilateral stn-dbs implantation experienced cerebrospinal fluid (csf) accumulation in the burr hole and meningitis within the first month postoperatively, where as the patient in the bone group presented superficial tissue infection.Both patients were treated with intravenous antibiotics, and no clinical conditions that potentially required removal of the dbs systems were observed.2.It was reported that 1 patient implanted for parkinson's disease that underwent bilateral stn-dbs implantation had lead migration of 1.7mm.However, no revision surgery was necessary and there wasn't any clinical worsening postoperatively or at 1-year follow up.3.It was reported that 6 patient's implanted for parkinson's disease that underwent bilateral stn-dbs had high impedances (4,000-10,000 ohms) observed in six contacts across four patients.The high impedances did not exhibit any significant correlations with decreased updrs iii scores and ledd values between the preoperative period and 1-year follow-up.4.It was reported that 30 patients with parkinson's disease underwent bilateral implantation and experienced on average 0.92mm of lead migration.There was no statistically significant difference between the groups.Because both groups exhibited only a mean migration of 0.9mm inferiorly, a revision surgery was unnecessary.Moreover, because the patients didn't exhibit clinical worsening due to the migration postoperatively and after 1 year of follow up contact change was also unnecessary.The patients also experienced pneumocephalus with an average volume of 13.5cc between the bone cement and stimloc group that was shown to be related to the slight electrode migration, but was not found to have any clinical deterioration, and was pneumocephalus volume was independent to surgery duration, fixation method, and microelectrode numbers.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.

Manufacturer Narrative

Concomitant medical products: product id: 3389, lot#: unknown, product type: lead; product id: 3389, lot#: unknown, product type: lead; product id: 3389, lot#: unknown, product type: lead, product id: 3389, lot#: unknown, product type: lead.Other relevant device(s) are: product id: 3389, serial/lot #: unknown; product id: 3389, serial/lot #: unknown; product id: 3389, serial/lot #: unknown.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 of publication of the article as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14017308
• MDR Text Key: 293631428
• Report Number: 2182207-2022-00589
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• 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
• Date Manufacturer Received: 03/07/2022
• 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: 54 YR
• Patient Sex: Female