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

Model Number 37612

Device Problems Intermittent Continuity (1121); Electromagnetic Interference (1194)

Patient Problems Fatigue (1849); Insufficient Information (4580)

Event Date 12/30/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date is approximate.Year is confirmed valid.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 patient service specialist (pss) received call from patient rep stating that last week the patient fell (not related to dbs) and was hospitalized.The caller stated that they had an x-ray (of hand) and a ct scan (head, neck, brain) done, and wanted to know if the the procedures can turn the ins off.Pss reviewed hospital environments with the caller.The caller stated that the patient went to see their hcp yesterday to ensure nothing was wrong with the dbs.The caller stated that at the time of the appointment, the hcp noticed the ins was turned off even though the ins was not suppose to be off.The caller stated that the patient has been having a lot of dementia due to their parkinson for about 10-12 days.The caller stated that since the hcp turned the ins back on the patient been having a much better day yesterday, and is seems to be doing better today.The caller stated that the patient charges the ins regularly for about 45 minutes.The caller stated they charge the ins until they hear the charge complete tones , a nd added that in regards to recharging, everything has been normal.The caller stated that pss reviewed with the caller that the ins will automatically shut off if the battery gets below 25%.Pss reviewed with the caller that the ins manually needs to be turned back on even after completing a charging session.Pss reviewed with the caller how to connect to the dbs therapy app , but the caller was not with the patient to perform additional troubleshooting steps.Pss redirected the caller to the hcp to further investigate the ins.The caller stated that they have an appointment with the hcp in about three or four weeks and will follow-up with them at that time.The caller stated that the patient did not have symptoms of dementia, but stated that the patient did not have a lot of energy, because their heart was still in a-fib.

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

Additional information received from the consumer reported they had an appointment with their healthcare provider (hcp), but they couldn¿t determine why or when it turned off.

• 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: 18525864
• MDR Text Key: 333520913
• Report Number: 3004209178-2024-01061
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2021
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2024
• Date Device Manufactured: 08/25/2020
• 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: 81 YR
• Patient Sex: Male