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

Model Number 37612

Device Problems Communication or Transmission Problem (2896); Positioning Problem (3009)

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

Event Date 08/03/2022

Event Type  malfunction  

Event Description

It was reported that the patient was having trouble charging, their right stimulator was completely zero, off and they get really depressed.Additional information was received from the manufacturer's representative (rep) who reported that the wireless recharger light will turn green and then search for ins on right side, then turn amber.Medtronic rep had already tried to reset recharger but that did not resolve the issue.During call, recharger was reset again and issue was still not resolved.Email was sent to repair to replace recharger.Patient mentioned having problems recharging since implant.It was reported that the patient was unable to use the drape on left implantable neurostimulator (ins) and has to hold the wireless recharger (wr) to connect.The manufacturer's representative (rep) stated the pocket is down low by side breast.Additional information was received from the manufacturer's representative (rep) who clarified that the patient reported frustration charging both the right and left implants.With the left ins, the patient is having to manually hold it in place to charge and can be hard to find the right spot.The right implant seemed to be optimally placed, but the patient has difficulty connecting to that side too.The replacement recharger resolved the recharger issue.The patient can use both rechargers simultaneously for a faster charging session.The patient is still expressing frustration with optimal and hands free charging.The cause of the recharging issue was not determined, just speculation of pocket placement and the patient reports having dense breast tissue.

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 PARKINS
• 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: 15562125
• MDR Text Key: 306520478
• Report Number: 3004209178-2022-13037
• Device Sequence Number: 1
• Product Code: MHY
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2023
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2022
• Date Device Manufactured: 04/26/2022
• 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: 68 YR
• Patient Sex: Female