MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems Premature Discharge of Battery (1057); Low impedance (2285); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Impedance Problem (2950); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Therapeutic Response, Decreased (2271); Insufficient Information (4580)

Event Date 01/09/2014

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 3387s-40, lot# va0buyn, implanted: (b)(6) 2013, product type: lead.Analysis results were not available at the time of this report.A follow up report will be sent when analysis is completed.

Event Description

A healthcare professional from a clinical study reported that there was an elective replace replacement indicator (eri), the neurostimulator was approaching end of life which was noted on (b)(6) 2016 during device interrogation.The patient was unable to maintain adequate control of dystonia symptoms.During normal use on (b)(6) 2016 there was an electrode that showed signs of a possible short with low impedance of 244 ohms.It was thought that there was premature battery depletion.The implantable neurostimulator (ins) was replaced and following that the impedance had improved slightly, up to 349 ohms.Diagnostics/troubleshooting included impedance checks.The outcome was resolved without sequelae.Telemetry print out from (b)(6) 2016 for the device that was replaced on that day indicated eri, with one electrode out of range on the right c/10-244.Telemetry print out from (b)(6) 2016 for the device implanted on that day indicated that the neurostimulator status was ok, stimulation was off, and no electrode impedance were out of range.This was related to the device or therapy and not related to implant procedure.The patient's indication for use is dystonia and movement disorders.

Manufacturer Narrative

Analysis of the implantable neurostimulator found the battery was at normal end of life.Telemetry and output were okay.Device code was removed as it was no longer applicable to the event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a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 reported over the last few weeks the patient had been getting out of regulation (oor) and elective r eplacement indicator (eri) error messages on his programmer.

Event Description

Additional information received reported the event was a result of a battery end of life (eol).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received stating that there was a loss of benefit that was experienced.

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 was received reporting that on (b)(6) 2013, there was intermittent open circuit on contact #10 right lead.Utilizing the contact lead to ins battery drainage which was subsequently replaced on (b)(6) 2015.On (b)(6) 2016, there was no open circuit on contact 10.However, it was actually abit low at 247 ohms.The patient's system was complicated to program waxing and waning effects.The extension were explanted/replaced on (b)(6) 2018.The issue was resolved without sequelae on (b)(6) 2021.

Manufacturer Narrative

D10: section d information references the main component of the system.Other relevant device(s) are: product id 3387s-40; lot# va0buyn; implanted: (b)(6) 2013; product type lead.Product id 3708660; serial# (b)(6); implanted: (b)(6) 2013; explanted: (b)(6) 2018; product type extension product id 3708660; serial# (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.

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: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 5522437
• MDR Text Key: 41030888
• Report Number: 3004209178-2016-05250
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00613994934604
• UDI-Public: 00613994934604
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/20/2022

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 Expiration Date: 02/28/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2016
• Initial Date FDA Received: 03/24/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 09/22/2016; 05/02/2022; 05/10/2022; 09/27/2022
• Supplement Dates FDA Received: 04/25/2016; 09/15/2016; 09/26/2016; 09/20/2017; 05/05/2022; 05/10/2022; 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2013
• 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: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 70 KG