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

Model Number 37612

Device Problems Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); High impedance (1291); Impedance Problem (2950)

Patient Problems Neck Stiffness (2434); Shaking/Tremors (2515)

Event Date 08/09/2022

Event Type  malfunction  

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

It was reported that the caller saw monopolar impedance in the investigate range 4309-5524 ohms.Bipolar impedance was in the range of 2053-3604 ohms.The only bipole pair that was high was 11<(>&<)>8 at 4192 ohms.The patient programmed on 10+ and 9-, 190hz, 150usec @3.3 volts, patient left with 180hz, 120usec @1.8.The hcp lowered the stimulation parameter because patient felt pulling immediately after therapy was turned on.The caller didn't know how long patient's therapy has been off.Technical services(ts) suggested looking at usage data and also looking at whether therapy was on or off upon initial interrogation, since provider wasn't sure if the patient's therapy was on or off when they first came into the appointment.The patient saw the hcp because he had a little more tremor in either hand.Impedance from 2019 or 2020, also showed monopolar impedances high at c<(>&<)>8 4191 ohms, c<(>&<)>10 3976 ohms, 8<(>&<)>9 were 2134 ohms.Ts told caller since patient's symptoms are managed by dbs therapy, there is no concern for a system issue at this point, but suggested more monitoring.Finally, hcp mentioned having difficulty getting therapy impedance at times, where it displayed dashes, but she was able to eventually get therapy impedance.The troubleshooting steps that were taken on the call resolved the issue.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: 15250543
• MDR Text Key: 305419268
• Report Number: 3004209178-2022-10521
• Device Sequence Number: 1
• Product Code: PJS
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2022
• Date Device Manufactured: 06/13/2019
• 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: 68 YR
• Patient Sex: Male