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

Model Number 37612

Device Problems Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for dystonia and movement disorders.It was reported that the patient had an overdischarge.Caller states the healthcare provider was not able to interrogate the ins yesterday in office with the clinician programmer and caller inquired about what they need to do to get the ins back up and charging.It was reviewed how to follow power reset mode.Continue recharging and clear the power on reset as soon as the ins is 25% charged.The rep said no external equipment was connecting with the implant, they are getting the reposition antenna message.The rep could not start a power reset mode session because he only held the keys down for 3 seconds.No symptoms were reported.No further complications were reported or anticipated with this event.

Manufacturer Narrative

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

Event Description

Additional information was received from the rep indicating that no symptoms were reported.Actions/interventions included on (b)(6) 2019, they did a reboot to get patient out of overdischarge and then continued to charge for 3 hours prior to leaving and once patient got to 25% charge.The cause of the overdischarge and inability to interrogate was not determined.The issue is resolved, they were retrained on the recharging process.This information was confirmed with the physician.

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: 8275899
• MDR Text Key: 134064509
• Report Number: 3004209178-2019-01687
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR