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

Model Number 37612

Device Problems Failure to Interrogate (1332); Communication or Transmission Problem (2896)

Patient Problem Insufficient Information (4580)

Event Date 10/14/2023

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 wireless recharger (wr) was not connecting to the implantable neurostimulator ins.The caller said that this was the first day they tried to charge the ins after the implant (it was implanted on (b)(6) 2023). the caller stated that there was not any swelling around the incision site. the patient said they checked the ins battery status two days after, on (b)(6) 2023, which was 75%.The patient mentioned a problem where "it couldn't find the battery." the patient said the recharging app showed an 'error code 508, contact clinician and provide your profile code' on (b)(6) 2023.Pss had the caller exit all apps and restart the process.Pss had the caller attempt to connect the wr to the ins, but it would not connect.Pss had the caller reposition the wr over the ins, but the issue persisted.  pss had the caller reset the wr off the docking station and attempt to connect to ins again, but the problem persisted; the patient could only connect to the ins for a moment before it returned to searching.Pss sent an email to repair to replace the wr.Pss redirected the patient to the hcp if the issue persists with replacement wr.Additional information was received from the patient that they received the wr, but the replacement will still not stay connected to the ins.The patient stated that "it's a little humpy there" regarding the ins site.The caller said they wanted to check the ins battery status with the communicator.When attempting to connect to the dbs therapy application, the caller saw a "no device response " message on the screen.Pss redirected the caller to the hcp to further investigate.

• 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: 17981125
• MDR Text Key: 326409732
• Report Number: 3004209178-2023-18064
• 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: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2023
• Date Device Manufactured: 08/08/2023
• 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
• Treatment: SEE H10...
• Patient Age: 71 YR
• Patient Sex: Female