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

Model Number 37612

Device Problems Energy Output Problem (1431); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 06/18/2022

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 patient wasn't able to adjust stimulation because they would get "service code 528, contact clinician, the neurostimulator is providing less than requested therapy" in the dbs therapy app.The circumstances that led to the reported issue were asked but unknown.The patient said they got a mouth guard that has metal in it that they had started wearing and then after that they started seeing the 528 message.The patient wondered if this could cause the issue, and it was reviewed this wouldn't be expected to be related.During call, patient was walked through going into dbs therapy app, therapy was on and ins battery was 75%.The patient said the day the 528 code came up the ins was 100% charged.The patient went into the therapy option of the dbs app and was on the tremor group but wasn't able to adjust stimulation without getting the 528 message.The patient had group b and mri group.The issue was not resolved.The patient was redirected to their healthcare provider to further address the issue.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: 14758514
• MDR Text Key: 302476988
• Report Number: 3004209178-2022-07926
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000384357
• UDI-Public: 00763000384357
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2022
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2022
• Date Device Manufactured: 10/26/2021
• 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: 75 YR
• Patient Sex: Female