MAUDE Adverse Event Report: MPRI SENSIGHT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number B3300542M

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

Event Type  malfunction  

Event Description

Information was received from a healthcare provider (hcp), via the manufacturer¿s representative (rep), who reported when the surgeon tried to remove the stylet from the lead, it was stuck and would not come out.Prior to attempting removal of the stylet, the burr hole clip was closed with ease, and the depth stop was completely removed.The surgeon then proceeded to hold the lead at the clip with a ¿shoded¿ instrument and was instructed to hold very gently.When the surgeon attempted to remove the stylet, it was stuck and would not come out.The surgeon administered additional force, and the clip popped open.He re-closed the clip and attempted to remove the stylet again.He again held the lead at the clip with his instrument.He was able to get the stylet out but was much force.It seemed to break free from the force after the tip had passed the pinch point of the clip.O-arm spin showed the lead 1mm deep from intended target.It was concluded that the two dorsal contacts were in stn and the lead was left implanted as is.It was unknown what led to the issue.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative (rep) reporting that a leksell frame, fhc to-target reusable cannula, and fhc depth stop were used.The depth stop screw had a silicone tip.The depth stop was applied at the top of the lead.This depth stop had been used previously.There was no burr hole device installed on the countersink and the burr hole site was clear of debris/bone chips.A centering tool was used to install the burr hole device.Regarding the lead, before implantation, the lead looked normal and was not soaked in any liquids.The trajectory of the implanted lead was about 60 degrees and 15 degrees.The lead did not appear bowed before attempting to remove the stylet.The surgeon attempted to remove the stylet after securing the burr hole clip.After the stylet was removed, it appeared bent.This was the surgeon's first sensight case.The rep concludes the issue was that the surgeon was squeezing the lead too tight.

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.

• Brand Name: SENSIGHT
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12850768
• MDR Text Key: 281073272
• Report Number: 2649622-2021-23194
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000426408
• UDI-Public: 00763000426408
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2023
• Device Model Number: B3300542M
• Device Catalogue Number: B3300542M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2023
• Date Device Manufactured: 10/15/2021
• 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 Age: 66 YR
• Patient Sex: Male