MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Additional information was received: it was reported that the cause of the movement of the ins, charging issues, and device being off wasn¿t determined.The patient was scheduled to see the doctor on (b)(6) 2019, the issue hadn¿t resolved.Additional information was received from the rep reiterating that the patient couldn¿t charge or communicate with the external equipment.Possible overdischarge was reviewed.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative (rep) reporting that the they were with the patient to pull it out of overdischarge.They were reviewed how to start a power reset mode session.They discovered that the battery was in power on reset (por) mode.Steps were taken to reset it and they were able to charge battery and interrogate to find in the "report" that it had not been charged since (b)(6) july.They are committed to maintaining a routine charging regime.

Manufacturer Narrative

No information for date of event.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for dystonia and deep brain stimulation (dbs) therapy indications.It was reported that the boyfriend of the patient called and said that the battery was off and that they cannot get it to charge.They also stated that the battery has been off for 2 weeks.Unknown if any environmental/external/patient factors may have led or contributed to the issue.Diagnostics/troubleshooting included trying to troubleshoot over the phone but was unable to.They recommended that the patient see her medical doctor tomorrow and have the battery interrogated.It is unknown if any interventions/actions were taken.The issue is not yet resolved.Additional information was received from the rep reporting that they called to check on the patient to see if the issue of "lack of communication" with her device was resolved.They had not yet seen the programming neurologist but will call for an appointment.They described that a week ago she had pain at the battery site and felt that the battery had moved.They recommended that her system be interrogated by the neurologist to troubleshoot if there are impedance issues or indications of a break in the system.No further complications were reported or anticipated with this event.

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: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 9323540
• MDR Text Key: 167549905
• Report Number: 3004209178-2019-21817
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1