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

Model Number 37612

Device Problem Failure to Deliver Energy (1211)

Patient Problems Shaking/Tremors (2515); Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 10/24/2022

Event Type  malfunction  

Event Description

It was reported by the patient's representative that it "seems like out of the blue the therapy is not working."  the patient's symptoms had seemed to increase for some time now.  they noticed that in between the patient having a broken wrist/arm surgery a couple of weeks ago and now, and it is 100 percent charged, the patient usually does not let it go very long (ins recharging).The caller said that yesterday they noticed the patient's handset showed the therapy was off (when using the recharger) and requested assistance to turn stim back on.Reviewed information (they must use the communicator dbs therapy app), and when the caller got the communicator, it did not power up; it was dead.Recommended plugging it in and calling back if they needed assistance to use it to turn the ins back on once the communicator was charged.Offered and emailed control equipment handbook and patient therapy manual.The caller said they were in pretty rough shape after the surgery on their broken wrist.Additional information received from the consumer reported there was a drastic increase in the patient¿s tremors and ability to control all aspects of physical movement.The consumer wasn¿t sure when therapy turned off, but they were looking forward to an appointment their healthcare provider (hcp) in february to tell them what day the device turned off as that would help explain why it happened as the hcp told them the device wasn¿t turned off in their previous surgery.The consumer was able to turn therapy back on, and keep it on, with assistance from the manufacturer.

Manufacturer Narrative

Other relevant device(s) are: product id tm90d0, serial# (b)(4), product type: accessory.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: 15970046
• MDR Text Key: 308107341
• Report Number: 3004209178-2022-16341
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• 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: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2022
• Date Device Manufactured: 08/14/2019
• 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: 63 YR
• Patient Sex: Female