MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI

Model Number 37612

Device Problem Failure to Deliver Energy (1211)

Patient Problems Shaking/Tremors (2515); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 37642 lot# , serial# (b)(6).Implanted: , explanted:.Product type programmer, patient.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

Information was received from a patient's representative regarding an external device.The caller reported that on monday the patient's implanted neurostimulator (ins) randomly turned off.The caller stated that the patient programmer was inside a drawer when that happened.The patient claimed that the ins battery was fully charged when the ins turned off.This morning, the patient again noticed that the ins was turned off.The patient noted that they were shaking bad and their voice was bad as well.The patient again claimed that the ins battery was 100% charged when they noticed the ins was turned off.The patient stated that they turned the ins back on, but then the ins turned off again and the patient was unable to turn it back on using the patient programmer.The patient again claimed that the ins battery was fully charged when they noticed the ins turned off yet again.The patient denied being around any sources of electromagnetic interference.The patient stated that they went to their neurologist today and the neurologist was able to turn the ins back on for the patient.The patient stated that their neurologist told them the ins battery was 100% charged when they turned the ins back on.The patient stated that the neurologist was concerned that the patient programmer was not working correctly and advised the patient to call patient services and have it replaced.During the call, agent had the caller check the status of the ins using the patient patient programmer.The ins was turned on and the ins battery level was ok.Agent reminded the patient that the ins can turn off if the ins battery level gets too low.Agent advised the patient to closely monitor the ins charge level going forward.Agent reviewed that the patient programmer was working correctly, but the patient pushed back and said their neurologist wants the patient programmer to be replaced.Agent sent an email to repair to replace the patient programmer.

Manufacturer Narrative

Concomitant medical products: product id: 37642, serial#: (b)(6), product type: programmer patient.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 consumer.Reported, the circumstances that led to the device turning off, was the patient watching t.V.And the device being in a drawer in the bedroom.The patient went to the doctor and they sent the device back.Which, resolved the issue.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 17558383
• MDR Text Key: 321287110
• Report Number: 3004209178-2023-14385
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00613994934611
• UDI-Public: 00613994934611
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 09/08/2023
• Supplement Dates FDA Received: 09/14/2023
• Date Device Manufactured: 04/22/2013
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 79 KG