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

Model Number 37601

Device Problems Corroded (1131); Failure to Interrogate (1332); Failure to Power Up (1476); Battery Problem (2885); Communication or Transmission Problem (2896)

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

Event Date 10/20/2021

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 37642 serial# (b)(6) product type programmer, patient section d information references the main component of the system.Other relevant device(s) are: product id: 37642, serial/lot #: (b)(6) , udi#:(b)(4) h3: analysis of the 37642 programmer serial number (b)(6) revealed a corroded telemetry board.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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

It was reported that the patient programmer (pp) would not power on, and when they checked the battery compartment, they noticed one of the batteries were corroded a little bit.Before calling the patient's healthcare provider (hcp) and manufacturer representative (rep), they cleaned out the battery compartment, put in new aaa batteries, and confirmed the pp powered on.However, the pp would not synchronize with the implantable neurostimulator (ins) because it never advanced beyond the 'sync' screen (the screen with the check mark in the middle and warning symbol in the upper left-hand corner).The telemetry failure initially occurred while the antenna was connected to the pp, but it persisted after they detached the antenna and placed the pp directly against the ins.The patient's hcp and re had them do the same troubleshooting that they already completed before calling them, and advised them to call patient services for further assistance.No further troubleshooting was necessary.They mentioned that it had "been a long time" since the patient last used their pp, noting that the aaa batteries were in it the whole time.To prevent this from happening again, it was advised they have the patient remove the aaa batteries from the pp if they know they won't be using it for an extended period of time.They understood.A replacement pp was sent.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 18605512
• MDR Text Key: 334177502
• Report Number: 3004209178-2024-02652
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00763000175719
• UDI-Public: 00763000175719
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2021
• Date Device Manufactured: 04/30/2019
• 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: 77 YR
• Patient Sex: Female