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

Model Number 37612

Device Problems Unstable (1667); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Scar Tissue (2060); Swelling/ Edema (4577)

Event Date 02/03/2023

Event Type  malfunction  

Event Description

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was pt said they just put in a rechargeable ins, they have tried recharging a couple of times since saturday but recharging is not going easy they tried going from 75% to 100 but it did not achieve 100% and today they are at 50% but it connects but keeps losing it, the handset goes to: searching for device.Worked with pt to try and reposition the charger and pt described connecting then loosing the connection they had turned the sound off.Worked with pt to reset the charger (npw028615n) by holding down the power button for 45 seconds and restart the handset then try again.Pt connected then it went back to searching for device.Pt said they were holding it in place with their hand they had called the manufacturer representative (rep) about their difficulty today and rep is sending them a drape.Pt palpated the area and said their incision is scabbed over and the ins site is a little bit raised/rounded where the ins and incision are but not much.Reviewed post surgical healing and recharging considerations, swollen tissue may cause interference and redirected to their doctor.Pt was concerned and did not want their ins to go dead.Offered and sent email to rep regarding charging diffic ulties.The issue was not resolved.The patient was redirected to their healthcare provider (hcp) to further address the issue.The patient's relevant medical history included, pt said they have had 2 other dbs implants before this one.Their last one was the 5 year model.Their last one went dead on them.During the callback pt said they had continued to try to recharge and got it to 75% today.

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
• 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: 16315965
• MDR Text Key: 309036822
• Report Number: 3004209178-2023-01739
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000519247
• UDI-Public: 00763000519247
• 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: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2023
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2023
• Date Device Manufactured: 11/17/2022
• 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: 55 YR
• Patient Sex: Male