MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI

Model Number 37603

Device Problems Failure to Deliver Energy (1211); Failure to Interrogate (1332); Battery Problem (2885); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Shaking/Tremors (2515); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2023

Event Type  Injury  

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

It was reported that the patient was seen in the outpatient clinic because of a problem with his right arm.When communication with the implantable neurostimulator (ins) on the left side was tried using the patient controller, there was no response.When checking using the clinician tablet, it was displayed, "interrogation failure: failed to communicate with the ins.Code: 3bd98c47." on the right side, communication was established with the controller.Stimulation voltage (v) 2.3 ma, pulse width 90s, impedance (o) 969, rate (b)(6) , monopolar.No environmental/external/patient factors that may have led or contributed to the issue are known.Both inss will be replaced on october 25, 2023.For the left side ins, which had poor communication, it was able to communicate between the ins and clinician tablet by performing a "neurostimulator reset." it was confirmed that therapy was resumed when the device was reset.There was no data damage on either ins.Additional information was received from engineering that the device was likely at eos or with a very low battery and having trouble communicating.During the interrogation the sc tells the cp app it experienced a por and the ins firmware is an ¿invalid app¿. because of this the clinical programmer app fails to interrogate the sc.Since the patient was having an issue on the corresponding side and the notes above indicate, it is believed therapy was off and replacement is needed.The battery of the left ins was suspected to be depleting too fast because the communication was not established and the therapy stopped.However, when communication was restored on october 25, 2023, the therapy resumed and battery depletion was found to be normal.Since the therapy resumed and the battery did not deplete too fast anymore, the replacement of the batteries on both sides scheduled for october 25, 2023 was not carried out.There were no reports of any defects with the right battery.The right battery was scheduled to be replaced at the same time as the left battery at the physician's discretion.A reset was performed and the problem seemed to be resolved, but then the same problem recurred.The doctor decided that this might be a problem with the neurostimulator and decided to replace it.Additional information was received from the manufacturing representative (rep) stating that there was a defect in the right-sided implantable neurostimulator (ins) aswell, so the battery was replaced.A reset operation was performed for the left-sided ins.It was restored and the treatment was resumed, but the same defect occurred and became completely impossible.The treatment was stopped and the right ins was replaced with the left ins.The issue was resolved at the time of this report.

Event Description

Batteries on both sides were replaced.The patient had symptoms of tremor on the right side even though neither the patient nor the physician had turned off the stimulation, so telemetry was attempted on the left ins because stimulation was suspected to be off.When attempting to perform telemetry using the clinician tablet the device could not be detected.It was reset and telemetry was attempted again but the device was not detected.Telemetry was attempted again using the same flow with a different tablet but was unsuccessful.Unable to perform telemetry with the device, so could not obtain the data report.Telemetry was also performed on the right ins with no issue.The physician commented that there were no problems with the right ins and suspected a device malfunction with the left ins given that stimulation was turned off repeatedly.However, it cannot be determined whether a defect has occurred on the right side, so the ins will be returned for analysis.The impedance were normal and the session report did not mention that the battery level was por at 2.9v.The engineer's report states that a por was observed.

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 from a manufacturer representative (rep) reporting that after reset, the left ins battery was at 2.9v.The doctor considered this ins was out of order and replaced it on nov-29th.The patient had tremor on the right side even though neither the patient nor physician had turned stimulation off.Telemetry was attempted on the left ins because stimulation was suspected to be off.When attempting to perform telemetry using the clinician tablet, no communication was possible/device could not be detected.It was reset and telemetry was attempted a couple of times, with same result.Therefore, no data logs was obtained.The impedance was normal.Telemetry was performed on the right ins and communicated without problems.The doctor indicated that the fact stimulation was turned off repeatedly on the left ins was very likely a device malfunction, not a patient's living environment, etc.There were no issues with the right ins, however, it could not be determined whether a defect had occurred on the right side, so the device on the right ins was replaced with the left ins.The issue was resolved.

Manufacturer Narrative

Refer to manufacturer report #2182207-2023-02348 for related device.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

The cause of the por, stimulation output issue and other issues has not been determined.It is unknown if the patient is receiving effective therapy.

Manufacturer Narrative

H3: analysis of the implantable neurostimulator (ins) revealed that the ins was functional.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18256344
• MDR Text Key: 329604480
• Report Number: 3004209178-2023-25084
• Device Sequence Number: 1
• Product Code: PJS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2020
• 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 H11...."
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 59 KG