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

Model Number 37601

Device Problems Failure to Interrogate (1332); Communication or Transmission Problem (2896); Operating System Becomes Nonfunctional (2996)

Patient Problems Dyskinesia (2363); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during intra-operative programming session a red warning was seen while measuring impedances on group c, which forced the session to end/crash.The process was repeated, but the warning was seen again despite several attempts, it was not possible to test the therapy impedance.The warning stated the communicator was unable to connect to the implantable neurostimulator (ins) even with the communicator directly on top of the ins.Group c amplitude was left blank, and a new ins was used to complete the procedure.After the procedure, the rep was able to successfully perform therapy impedance test on group c with the ins.There were no symptoms reported.Additional information was received: it was reported that the new percept ins was implanted successfully and had no communication issues.However, due to the issues with the previous ins they were only able to convert amplitudes for groups a and b.For group c they weren't able to conduct a successful therapy impedance resulting in no amplitude being programmed.The managing neurologist was ok to proceed regardless as pulse width and frequency converted with the replacement feature, but not amplitudes.The previous ins was the ins being replaced and therapy impedances were ok, although there were a few issues converting group b (e.G.Getting a therapy impedances).They thought it shut down the session there too as the patient was stuck on that program and quite dyskinetic.They re-interrogated and got the results, but no such luck with group c.The communicator was on the patient like it was for other sessions.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id a610 lot# serial# unknown implanted: explanted: product type software product id a610 lot# serial# unknown implanted: explanted: product type software.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

Section d information references the main component of the system and other applicable components are: product id a610 lot# serial# unknown implanted: explanted: product type software product id a610 lot# serial# unknown implanted: explanted: product type software correction for software fdm, fdr, and fdc codes 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 session was exited out of and restarted multiple times and it didn't resolve the error.Only later, post explant, was the rep able to perform the test.It was stated that the ins needed to be reset and the issue was believed to be resolved.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id a610 lot# serial# unknown implanted: explanted: product type software product id a610 lot# serial# unknown implanted: explanted: product type software 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): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 12652266
• MDR Text Key: 277141998
• Report Number: 3004209178-2021-15501
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR