MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; Stimulator, electrical, implanted, for parkinsonian tremor

Model Number 37612

Device Problem Noise, Audible (3273)

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

Event Date 07/05/2023

Event Type  malfunction  

Event Description

Information was received from a patient regarding an external device.The reason for call was patient stated that she charged her implantable neurostimulator (ins)  this morning and was able to charge her ins until it got to 100%.Patient stated that the battery was still beeping and she looked over and saw the battery light was flashing red.Patient services (pss) reviewed with the patient that the wireless recharger (wr) will turn red when it cannot find the ins.The patient stated that she had the wr on the bed but can't remember if she turned it off after recharging.Patient service specialist asked if the recharging session was done and patient states she did not know.Patient was concerned that there might be a sound coming from the implant.The circumstances that led to the reported issue were unknown.Troubleshooting was unable to be performed as patient service specialist had patient start a charge se ssion.The troubleshooting steps that were taken on the call resolved the issue.On the call the external equipment was working properly.Pss redirected the patient to follow-up with hcp if she thinks she is hearing a sound coming from her ins.No symptoms reported.

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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 parkinsonian tremor
• 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: 18150255
• MDR Text Key: 329654221
• Report Number: 3004209178-2023-21797
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000100360
• UDI-Public: 00763000100360
• 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: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2021
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2023
• Date Device Manufactured: 08/10/2020
• 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: 77 YR
• Patient Sex: Female