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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)

Patient Problems Shaking/Tremors (2515); Ambulation Difficulties (2544); Electric Shock (2554); Paresthesia (4421)

Event Type  malfunction  

Event Description

It was reported that patient was scheduled for surgery (no allegation related to dbs device) this thursday and inquired about using the handset and communicator to turn therapy off.The caller stated the patient saw their hcp last week as the patient had started to shake, and was not walking as good and they found out the dbs was turned off.The caller stated they were not sure how or when the patient's therapy turned off and mentioned the patient had a cat scan back on march 26th, and inquired about relation.Caller also mentioned the patient had previously had a surgery on their hand (date not provided), and therapy was turned off by the anesthesiologist, and stated that maybe the dbs had not been running all that time and added they felt the patient would have had their therapy turned back on after as they would have been shaking a lot more if it was off.The caller stated today when therapy a was turned on, the patient experienced shocking/jolting/tingling (caller confirmed patient was not harmed) sensation that did not subside like it normally would after 10 seconds when therapy would be turned back on after being off in the past, and that when b was turned on, the ins acted like it was not working.The caller was not sure if they were using the equipment correctly as the therapy was showing 100 for both groups a and b and stated they reached out to the hcp to confirm therapy settings were correct, but had not heard back yet.The caller mentioned that prior to using the new external equipment, the caller had issues with the patient programmer where they messed with it for a couple of days and felt that it was not working anymore.They stated they tried to change therapy to off and described the process of adjusting therapy settings.Pss reviewed with caller how to use patient programmer and caller stated they did press the turn therapy off/on button, and that they did not want to troubleshoot or address that as they were learning how to use the handset and communicator now.

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: 15232553
• MDR Text Key: 305177865
• Report Number: 3004209178-2022-10371
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2022
• Date Device Manufactured: 05/10/2018
• 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 Sex: Male