MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 37601

Device Problems Display or Visual Feedback Problem (1184); Loss of Data (2903)

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

Event Date 09/06/2022

Event Type  malfunction  

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.

Event Description

It was reported that the manufacturer's representative (rep) was at the hospital for a replacement of the patient's current implantable neurostimulator that was implanted in (b)(6) 2020, but was never registered.The caller interrogated the ins with tablet and noted that the only thing she saw was the patient's name, birthday, ins serial number and 'setup'.The caller notes no programming was in the device, no settings--it was as though the ins was never set up.The caller states she saw no messages on the tablet when first interrogating the ins.The date of implant on the tablet showed (b)(6) 2000.The ins has voltage of 2.88v.The caller stated the hcp had told someone at the hospital when they interrogated yesterday that the doc believed the ins may have never been activated or turned on--there was no indication that the doctor saw or did not see a message/error upon interrogation.Tss speculated that considering ins was not registered and the battery voltage is still fairly 'healthy' (ie it seems the voltage may be at a level where it depleted as though it was on the shelf) that the ins never being programmed makes the most sense, especially since the patient had a regular replacement regimen of around 3 years.Tss reviewed caller could elect to program current device, pull mdt file/logs or they could pursue replacement and send the ins back for analysis.Additional information was received from the manufacturer's representative (rep) who clarified that the device was originally going to be replaced because the clinician believed the battery was depleted.The battery was not replaced.It was not confirmed that the device was never programmed.Actions taken was the a program report was able to be obtained and it showed an implant date of (b)(6) 2020.The rep programmed the device with the settings.The issue was resolved at this time.Additional information was received from the rep.The ins was not replaced they kept the current ins and reprogrammed it.Additional information was received from the rep.The device was programmed.Cause of event apparently was an older clinician programmer that communicated with the patient¿s device and deleted their settings.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 15462387
• MDR Text Key: 306337656
• Report Number: 3004209178-2022-12173
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000310332
• UDI-Public: 00763000310332
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2022
• Date Device Manufactured: 03/30/2020
• 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: 70 YR
• Patient Sex: Female