MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI

Model Number 37612

Device Problem Battery Problem (2885)

Patient Problems Nausea (1970); Dizziness (2194); Insufficient Information (4580)

Event Date 03/04/2024

Event Type  malfunction  

Event Description

Healthcare provider (hcp) states the patient (pt) reported to her that their charger showed an image of doc and is only charging the implantable neurostimulator (ins) for 15 min when it usually charges for an hour.The hcp did not know what the letters or numbers were that corresponded with the doctor image the pt saw.The patient called back and repeated information regarding the ins getting fully charged in 15 minutes when it used to take an hour and that they were seeing a 'contact clinician' screen on their recharger.Agent had the patient start a recharge session and they saw an informational por screen.Agent reviewed meaning of por and how to bypass the por message by pressing the audio key on their recharger.The patient confirmed they were able to charge the ins normally.Agent then had the patient synchronize their patient programmer with the ins and they immediately saw the informational por screen.The patient was able to successfully clear the informational por and turned stimulation on.As soon as stimulation was turned on, the patient's right foot felt funny, their head was spinning, dizzy, and they felt nauseous.The patient confirmed that all of those symptoms improved by the end of the call.Agent reviewed that the duration of the ins recharge sessions should return to normal now t hat stimulation was turned on.The patient stated that they first noticed the por message on their recharger maybe a month ago or less.

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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 18859113
• MDR Text Key: 337754366
• Report Number: 3004209178-2024-06515
• Device Sequence Number: 1
• Product Code: PJS
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2012
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Date Device Manufactured: 05/26/2011
• 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: 76 YR
• Patient Sex: Female