MAUDE Adverse Event Report: NEURO - VILLALBA ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 37603

Device Problems High impedance (1291); Peeled/Delaminated (1454)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced symptom return.No abnormalities revolving around factors that led to the issue were re ported.Troubleshooting involved trying to measure impedances several times.An x-ray was made.They applied stimulation to different contacts.Intervention involved a revision surgery and the extension was replaced.When changing the extension the end of the lead was exposed.It seemed that the insulation was gone between the contacts.The cable was changed, attached to the lead and the battery and all impedances were within range again.The issue was reported to be resolved.

Manufacturer Narrative

Concomitant medical products: product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2022, product type: extension.Other relevant device(s) are: product id: 37085-40, serial/lot #:(b)(4), ubd: 05-may-2015, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Continuation of d10: product id 37085-40 lot# serial# (b)(6) implanted: 2011-(b)(6) explanted: 2022-(b)(6) product type extension 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 had 2 activa sc's and the right side everything was well, but the left side had problems.There was a replacement in 2020 and the problems started in(b)(6) 2021 with impedances being out of range.The patient would get an oor message and then therapy would worsen, so they visited the hcp.After measuring impedances at 3v the impedances were lower, but still not within range.When the hcp selected a different contract the oor disappeared.The patient got an oor message again and therapy worsened.X-rays were taken and shown no abnormalities nor any falls.Additional information was received: it was reported that the patient experienced symptom return.No abnormalities revolving around factors that led to the issue were reported.Troubleshooting involved trying to measure impedances several times.An x-ray was made.They applied stimulation to different contacts.Intervention involved a revision surgery and the extension was replaced.When changing the extension the end of the lead was exposed.It seemed that the insulation was gone between the contacts.The cable was changed, attached to the lead and the battery and all impedances were within range again.The issue was reported to be resolved.

Manufacturer Narrative

Continuation of d10: product id 37085-40 lot# serial# (b)(6)implanted: (b)(6)2011 explanted: (b)(6)2022 product type extension 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 was received: it was reported that the patient was implanted 11 years ago.The cause of the insulation layer being gone was unknown.A new ins was implanted due to the other one getting older, there were no issues with it.

Manufacturer Narrative

Continuation of d10: product id 37085-40 serial# (b)(6) implanted: (b)(6)2011 explanted: (b)(6)2022 product type extension h3: analysis of the extension had shown that the conductors were broken in the body towards the proximal end.Analysis also identified environmentally assisted degradation of the insulation at the proximal end of the extension.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: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba,pr MN 00766
• Manufacturer (Section G): NEURO - VILLALBA; call box 6001; villalba,pr MN 00766
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14939300
• MDR Text Key: 295403759
• Report Number: 2182207-2022-01270
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: Male
• Patient Weight: 130 KG