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

Model Number NEU_INS_STIMULATOR

Device Problems Malposition of Device (2616); Difficult to Open or Close (2921)

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

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: b32000, serial/lot #: unknown ; product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the health care provider (hcp) was unable to close the right-side burr hole device during procedure.The hcp also discovered that the lead was misplaced while attempting to close the burr hole device.A new lead was used to place in correct position and a new burr hole clip and cover were used to complete the procedure (the same burr hole base was used).The burr hole cover device was closed and it was confirmed the lead was in the correct position.No symptoms were reported as a result of the event.Additional information was received indicating it was not determined what may have led or contributed to the lead misplacement.

Event Description

It was reported the hcp had used the new lead system prior to this implant procedure.This procedure was a bilateral case and hcp used a 14 perforator/drill to create both burr holes.The burr holes were not countersunk.The centering tool was not used to center the base ring in the burr hole/tighten the bone screws.It was not known if there was any noticeable bone still visible within the burr hole on the right side that could have interfered with burr hole cover closing.The hcp had difficulty seating the right-sided clip assembly into the base ring.It was further clarified the hcp had difficulty closing both the clip assembly and the cover.It was thought the lead was positioned at the end of the clip assembly.The hcp tried re-orienting the clip assembly within the base ring.A new clip was installed in the same orientation as the first clip with the issues closing and when the new lead was placed within the clip assembly it was positioned approximately in the same location in the clip.

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: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 12229268
• MDR Text Key: 263591757
• Report Number: 2182207-2021-01301
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• 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: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1