MAUDE Adverse Event Report: FHC INC NEXFRAME; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number DB-2040

Device Problems Break (1069); Insufficient Information (3190)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/20/2023

Event Type  malfunction  

Event Description

Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator (ins).The reason for call was rep said healthcare provider (hcp) couldn't get the nexframe out and he ended up snapping the screw, half of the screw came out but the other half is still in patient's skull.Rep to send half of the screw back.Troubleshooting was not required.The issue was not resolved through troubleshooting.

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: NEXFRAME
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): FHC INC; 1201 main street; bowdoin ME 04287 7302
• Manufacturer (Section G): FHC INC; 1201 main street; bowdoin ME 04287 7302
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18211322
• MDR Text Key: 329036167
• Report Number: 1226598-2023-00001
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00873263007808
• UDI-Public: 00873263007808
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2024
• Device Model Number: DB-2040
• Device Catalogue Number: DB-2040
• Device Lot Number: 311113823
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 11/27/2023
• Date Device Manufactured: 05/18/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female