MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA

Model Number 37601

Device Problems Failure to Deliver Energy (1211); Loss of Data (2903)

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

Event Type  malfunction  

Event Description

It was reported that in the study, subjects with previously implanted activa sc or pc devices receive temporary investigational firmware uploaded to their device to unlock novel stimulation patterns. the subject returns home for one week at a time with the pattern.If at any time the subject is uncomfortable, they are told to turn off the investigational pattern and return to their standard therapy using their 37642 patient programmer, followed by a call to their doctor.Yesterday, when a subject came into the clinic on (b)(6) 2022 for their planned research visit, the investigational firmware was no longer on the implantable neurostimulator (ins).When the ins was interrogated with the clinician programmer, commercial settings were programmed but stimulation was not on.This would be the expected state of the ins if investigational firmware had been removed from the device.The subject did not report any issues with therapy during the week at home or when they arrived at the clinic.The investigational firmware can be removed from the ins using the 37642 patient programmer or any clinician programmer (n¿vision or samsung tablet).The previous programming visit had occurred on wed.(b)(6) 2022.The subject reported that they did not use their patient programmer to revert to commercial settings during the week.Therefore, it is unclear how or when the research firmware was removed from the ins.Stimulation was turned on in the clinic using the commercial tablet.Additional information was received from a manufacturer representative (rep) reporting that they reviewed research programmer logs and commercial programmer logs.From the research programmer, they saw investigational stimulation was programmed on (b)(6) 2022 and the investigational firmware was no longer on the device and stimulation was off when using the investigational system during visit on (b)(6) 2022.From the commercial programmer, they saw the subject's standard therapy was turned on using the programmer on (b)(6) 2022.The cause of the missing investigational firmware from the ins was not determined.There are known methods for the investigational firmware to be removed, but they do not know for sure how it was removed.By design, when the investigational firmware is removed, the ins returns to a stimulation off state.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• 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: 13652797
• MDR Text Key: 296683944
• Report Number: 3004209178-2022-02694
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000175719
• UDI-Public: 00763000175719
• 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: Study,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2021
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2022
• Date Device Manufactured: 08/15/2019
• 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
• Patient Sex: Male