MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA

Model Number 37603

Device Problems Energy Output Problem (1431); Unstable (1667); Communication or Transmission Problem (2896); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Paresthesia (4421); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that for the past couple days when turning on the left implantable neurostimulator (ins) in the morning, the patient saw "call hcp-oor".The manufacturer's representative (rep) wanted to know the possible reasons.Technical services (ts) reviewed impedances, change in programming, potential for emi coupling onto system if system being checked multiple times in short order.Ts reviewed patient should get upper limit reached if patient had maxed out on programming but it didn't seem that patient was making any changes to the programming as everything with her therapy was good.The patient had been seen for normal programming/check of system a couple weeks ago.

Event Description

Additional information was received from the manufacturer's representative (rep) who reported that the cause of the oor message was not determined.It was clarified that the message comes on every time the patient tries to interrogate their patient programmer to their ins.Actions taken to try to resolve the oor message was to turn the programmer off and on again, changing the voltage up and down, but the patient could only decrease therapy settings without the oor message displaying.The patient was shown how to clear the oor message and see the home screen, but they could not turn the device voltage about the therapy of 3.4 volts.The oor still comes on every time they reconnect to the ins after turning the programmer off.The issue was not resolved, only resolved for the session by clearing it with the black oval shaped button on the programmer.The patient will see their neurologist to see if troubleshooting in person may help.The information was confirmed by the account.

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 the manufacturer's representative (rep) confirmed by the physician/account who reported tha t the cause of the ins flipping, difficulty communicating and the oor was unknown.Actions taken to resolve the issues was the patient will get a surgical consult.The issue was not resolved at this time.

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.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's representative (rep) regarding an implantable neurostimulator (ins).The reason for call was the caller indicated that the patient is experiencing paresthesia sporadically.The caller indicated that the patient started to experience this sensation after the ins replacement in march 2021.The ins that is causing the issue is in the left chest.The caller indicated that the x-ray shows that the ins is flipped.They are having some difficulty communicating with the ins.Sometimes the tablet will connect and sometimes it will not.The patient has been getting oor message.And today in the office the system was in oor during the appointment.The caller indicated that the impedance values all were normal.The issue was not resolved through troubleshooting.

• Brand Name: ACTIVA
• 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: 14470767
• MDR Text Key: 292400005
• Report Number: 3004209178-2022-06619
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000384340
• UDI-Public: 00763000384340
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2022
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2022
• Date Device Manufactured: 01/15/2021
• 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 Age: 76 YR
• Patient Sex: Female