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

Model Number 37612

Device Problems Display or Visual Feedback Problem (1184); Delayed Charge Time (2586); Charging Problem (2892)

Patient Problems Erythema (1840); Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2022

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 37761, serial# (b)(6), product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: 37761, serial/lot #: (b)(6), h3:analysis of the 37761 recharger (rtm) ,serial number (b)(6), revealed a bent connector pin.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

Information was received from a patient's representative regarding an external device.It was reported the recharger was not charging up.The caller stated the desktop charger (dtc) was plugged in, but they were seeing the low recharger battery screen and they were not able to clear the screen or use the recharger as the recharger was not progressing in charge.Caller stated they had tried multiple outlets, but the issue persisted.Caller confirmed green light of ac power was on.Caller stated there was no visible damage to the dtc, connector pin, or recharger port.The caller stated the patient's ins was at 75% and they were quite frantic that the patient was unable to charge (see case #rtg0338528).It was also reported the they had too long of charging sessions and caused the patient discomfort and their skin got red. the caller informed patient services (pss) that this was nothing new and they were not calling about that.Additional information was received from the patient.Patient does not know what circumstances could have led to the event.There was no change in usage/activity.It stopped getting power from the wall.It was confirmed the replacement devices resolved the charging issues.

• 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: 18872259
• MDR Text Key: 337579884
• Report Number: 3004209178-2024-06715
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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: 03/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2022
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2016
• 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 H11...."
• Patient Age: 27 YR
• Patient Sex: Male