MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ITREL II; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 7424

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Malposition of Device (2616); Insufficient Information (3190)

Patient Problems Scar Tissue (2060); Discomfort (2330); Electric Shock (2554); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

It was reported that, about 10 years ago, the patient's implantable neurostimulator (ins) had developed instability and one of the wires got shocky or something and they were trying to run a new wire above it and could not get a new wire above it but the old system was getting kind of shocky.Patient said the ins was removed but they could not get the wires and electrodes out.

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.

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.

Event Description

Additional information received from the patient.It was reported the device was discarded.The battery was removed in 2010 during a gallbladder removal.It sat over the gallbladder area and was uncomfortable.It was already not functional as the wires had become shocky.The electrodes would not move.They tried to optimize the stimulation but the patient received extremely strong shocks while they were trying to reprogram it.Later they tried to run another wire above the old one but there was too much scar tissue.The old wires were still in the patient's spine.The patient had no more shocking since the battery unit was removed.An unsuccessful removal of the wires was attempted but was unsuccessful which was unfortunate as the patient needed a head mri but could not have it due to the electrodes they had.The patient did not have any future plans to remove it.

• Brand Name: ITREL II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 15951845
• MDR Text Key: 305186614
• Report Number: 2182207-2022-02290
• Device Sequence Number: 1
• Product Code: MHY
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/1996
• Device Model Number: 7424
• Device Catalogue Number: 7424
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2023
• 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
• Patient Sex: Female
• Patient Weight: 100 KG