MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; Stimulator, electrical, implanted, for parkinsonian tremor

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); Inappropriate/Inadequate Shock/Stimulation (1574); Electromagnetic Compatibility Problem (2927)

Patient Problems Pain (1994); Electric Shock (2554); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

D10.Section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_ext, serial/lot #: unknown, ubd: , udi#: ; product id: neu_unknown_lead, serial/lot #: unknown.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.

Event Description

It was reported that the patient is pretty much an expert in mind-body symptoms and therefore, they no longer use the system, the stimulator is switched off and they suspect the implantable neurostimulator (ins) is discharged because they have not charged it for a very long time.  the patient is also due to get the ins removed at some point, but the leads will most likely stay.With the stimulator switched off, the pain behind their ear/interference is much less, but it remains significant enough for them not to use wireless headphones.The patient is currently unable to use wireless headphones because they get pain from the emi it causes behind their ear.The pain generated is not physical interference like pressure from headphones.It feels very different to the feeling they experienced when they had a mammogram.The patient mentioned that the interference seemed to be in the wires themselves and only in the area behind their ear where they exit the skull and run down their neck.The issue has not responded to their tried and tested techniques but they continue to work at it.They mentioned that previously, there was a real electrical pain through the wires whenever the stimulator was switched on.The wires were revised and a sheath replaced that had a staple hole in it.This did not resolve the issue and the entire wire set was replaced but not the electrodes in their brain or the leads connecting to the rest of the system.The problem was not resolved.By this time, their occipital nerve was pretty jazzed up and was hurting at other times but a different pain.It was treated with injections which helped, and they had a new neurosurgeon at this point.They determined that the pain happened when it was one particular electrode set that was used, so they stopped using it and the pain when turning on/off stopped.However, the emi interference continued, but it wasn't much of an issue.However, it is an issue now as it's difficult to listen to music or books (they can't read well due to a processing issue) without using bluetooth equipment.It's been frustrating and limiting.The patient wonders if the issue is in the wire insulation.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: Stimulator, electrical, implanted, for parkinsonian tremor
• 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: 17467578
• MDR Text Key: 320472100
• Report Number: 2182207-2023-01554
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/07/2023
• 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