MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number 37612

Device Problems Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Charging Problem (2892)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2022

Event Type  malfunction  

Event Description

Information was received from a patient's representative (pt rep) regarding an implantable neurostimulator (ins).The reason for call was caller reported that the patient's battery stopped charging about 3 days ago.The caller mentioned the patient had dbs for parkinson's and dystonia.Patient services (pss) asked callers if both of the patient's ins's were not charging and they were not sure, and that they believed there was something going on with the recharger.The callers attempted to get in contact with the caregiver that was with the patient but were unsuccessful, but were able to get ahold of another member that provided the s/ns.Pss reviewed equipment and matching serial numbers, and the new member caller that was on another line mentioned the patient programmer was not working and could not provide any further detail and then further described that on the recharger, they saw a picture with a question mark and something that was on the side of it.As patient and equipment were not available during the call, pss was not able to troubleshoot and could not identify what the overall alleged issues were and documented reported information.The caller informed pss they would call ps back tomorrow to troubleshoot and address the issue once they were with the patient and the equipment.  the patient rep called back and repeated information regarding them thinking there was an issue with the patient's recharger and patient programmer.The caller stated that neither of the devices were communicating with either of the patient's inss.During the call, the recharger was showing the 'reposition antenna' screen and the patient programmer was showing the 'poor communication' screen.The caller said the last time the patient charged their inss was around (b)(6) 2021.Agent reviewed that the inss were likely overdischarged and redirected the caller to the patient's healthcare provider (hcp) to further address the issue.The caller repeated that the patient is immobile, but they will see what they can do about getting them in to see hcp.No symptoms reported.

Manufacturer Narrative

Continuation of concomitant medical product: product id: 37651, serial#: (b)(4), product type: recharger.Product id: 37612, serial#: (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator.Product id: 37642, serial#: (b)(4), 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 was received from the rep.The ins was overdischarged, the patient had not charged device in 6+ months.Actions taken to resolve the issue were power on reset was completed and ins was charged.The overdischarged and connection issues were resolved.This information was confirmed with the physician/account.

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 (M
• 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: 15804710
• MDR Text Key: 307982018
• Report Number: 3004209178-2022-15102
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2012
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 11/15/2022
• Supplement Dates FDA Received: 11/16/2022
• Date Device Manufactured: 06/14/2011
• 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
• Treatment: "SEE H10....".
• Patient Age: 62 YR
• Patient Sex: Female