MAUDE Adverse Event Report: MEDTRONIC, INC. ACTIVA

Model Number 37612

Device Problems Failure to Interrogate (1332); Battery Problem (2885); Communication or Transmission Problem (2896)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The event date is unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that about 2 to 3 months after implant, the patient has been having a lot of health problems (just had throat surgery) and she has been experiencing more "parkinson's-like symptoms in the right hand instead of tremors". the patient stated she was trying to use her patient programmer (pp) to check her therapy but kept getting poor communication. she confirmed was able to connect and charge her implantable neurostimulator (ins) just fine but when she tries to check her therapy with the pp, she just gets poor communication. the patient initially thought this screen was saying that her ins battery was depleted but the screen meaning was explained and the patient understood.The patient tried connecting to the pp on the call and again saw poor communication.The patient does not use a pp antenna.The patient mentioned that she has the pp that was with her previous ins and that one was also showing the poor communication screen when she was trying to check her ins.The issue was not resolved.A replacement pp was sent.Additional information was received from the consumer reporting they received the new pp, but it also shows the poor communication screen.The patient started an ins charging session and repeatedly saw the 'reposition antenna' screen.The possible causes of the 'reposition antenna' screen were reviewed.The patient confirmed the recharger antenna was positioned over their ins, but they mentioned that they are sure the ins battery is depleted because they haven't charged it for 2 months due to a lot of unrelated medical issues.It was reviewed that the ins is likely overdischarged because their recharger and patient programmers are unable to communicate with it.Additional information was received from a manufacturer representative (rep) reporting the battery was able to charge.The recharger was replaced with a wireless recharger (wr) and the issue was resolved.

Event Description

Additional information was received from a manufacturer representative (rep) reporting the battery was able to charge.The recharger was replaced with a wireless recharger (wr) and the issue was resolved.

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.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 received from the manufacturer¿s representative (rep) reported the patient stated it was hard to use so they didn¿t charge their device and therefore it depleted.

• Brand Name: ACTIVA
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 11689373
• MDR Text Key: 248763711
• Report Number: 2182208-2021-01543
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000100360
• UDI-Public: 00763000100360
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2021
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1