MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR

Model Number NEU_INS_STIMULATOR

Device Problem Material Deformation (2976)

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

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 10-feb-2025, implant date: (b)(6) 2021, udi#: (b)(4).Product id: 3708660, serial/lot #: (b)(4), ubd: 10-feb-2025, implant date: (b)(6) 2021, udi#: (b)(4).Note that only one of the above extensions was kinked, per the report; however, it was reported that it could not be determined which was kinked.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the extension was kinked, which was observed out of box.When inserted into the implantable neurostimulator (ins), there were no connection issues, so the surgeon proceeded with implant using the device.No symptoms were reported as a result of the event.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• 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: 11863081
• MDR Text Key: 252001547
• Report Number: 2182207-2021-00862
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2021

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 Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 05/21/2021
• 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
• Treatment: N/A.