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

Model Number 37602

Device Problem Energy Output Problem (1431)

Patient Problems Device Overstimulation of Tissue (1991); Burning Sensation (2146)

Event Date 12/04/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient had a burning sensation on top of their toes of both feet but the left foot was worse.The past couple of nights, the patient told them that the burning sensation was "bad".The burning sensation also happened during the day, but it was more of a nuisance for the patient at night because they could not sleep.During the call, they discovered that the patient had sores that were mostly on their toes, which they said was from the patient's feet rubbing against the sheets while they were in the hospital for implant surgery on (b)(6) 2021, they noted that they were not open sores and were just red.However, they and the patient did not feel that the burning sensation in the patient's toes were related to the sores.They and the patient felt that the burning sensation in the patient's toes were related to the therapy settings being too high.They tried to decrease the therapy settings, but they were unable to do so because they thought the patient programmer (pp) was "locked." they stated that they were able to get the pp to sync with the implantable neurostimulator (ins) to the point that they could see the ins battery level was ok and at "2.96 or something like that," and the amplitude was at "400." they did not indicate which ins they had synced with.During the call, they synced with the left ins and reported that the therapy was on, ins battery level was ok, and the amplitude was set to 4.00 for the right side of body.They asked how much they should decrease the amplitude.They were redirected to the patient's hcp to further address the issue.Refer to manufacturer report #3004209178-2022-00435 for related device.

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
• 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: 13214429
• MDR Text Key: 291309449
• Report Number: 3004209178-2022-00436
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000384333
• UDI-Public: 00763000384333
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2022
• Date Device Manufactured: 07/30/2021
• 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: 72 YR
• Patient Sex: Male